MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X20
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Foreign Body Embolism (4439)
Date of Event	08/01/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that: "during an onyx case, the balloon fractured and ended up occluding the right ica." on (b)(6) 2022, additional information received from the issuer: "were any additional procedures performed by the physician? thrombectomy after the balloon fractured." on (b)(6) 2022 - additional information received from the issuer: "could you please tell us what was the planned procedure? onyx injection through e2l for a fistula.Could you please give us information on patient's status? withdrew care.Can you please confirm that there is no patient injury? no.Was the patient's anatomy tortuous? yes.".
Additional Manufacturer Narrative
Balt usa reference number: (b)(4).The investigation was performed by supplier balt extrusion.Summary provided as follows: the affected catheter eclipse2l has not been returned to balt extrusion for inspection.This investigation is based on the incident description, the lot history records, and the data gathered during our post-marketing surveillance program for such failures.During our review of the lot history record (lhr) and the manufacturing process of the eclipse2l, we noted that: the braid, the tube, and the balloon are 100% controlled with a visual inspection during the manufacturing process.A tightness test of the balloon is also performed on every unit per manufacturing process instruction.The integrity of the microcatheters is 100% controlled.We did not observe any anomaly that could potentially explain the reported issue.There is no other complaint registered on this lot number to date.The incident description mentioned that the eclipse2l was broken during injection of onyx: "during an onyx case, the balloon fractured and ended up occluding the right ica." we were not able to identify the conditions under which the issue occurred and which manipulations were applied by the physician.However, based on our post-marketing surveillance program, such fractures are likely caused by the embolic agent reflux beyond the catheter's distal extremity during the injection, then unlikely linked to the eclipse2l device.The damages mentioned ("thrombectomy after the balloon fractured.") could assuredly be linked to the device removal attempts following the device jailing which caused his rupture.In conclusion, the reported incident (rupture of the catheter after embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.Manufacturing records complied with specifications, and the product was not available for inspection.A comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.No such increase in the rate of occurrence has been observed.However, this issue will remain subject to continued tracking.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f211100553 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "during an onyx case, the balloon fractured and ended up occluding the right ica." (b)(6) 2022, additional information received from the issuer: "were any additional procedures performed by the physician? thrombectomy after the balloon fractured." (b)(6) 2022 - additional information received from the issuer: "- could you please tell us what was the planned procedure? onyx injection through e2l for a fistula.- could you please give us information on patient's status? withdrew care.- can you please confirm that there is no patient injury? no.- was the patient's anatomy tortuous? yes." (b)(6) 2022 - additional information received from the issuer: "care was withdrawn and patient expired." (b)(6) 2022 - additional information received from the issuer: "the underlying condition was a subarachnoid hemorrhage- the patients aneurysm ruptured.As i stated over the phone initially when we spoke the patient was already a hunt hess grade 4/5.Meaning an 80-90% chance of mortality.There were no prior procedures done.Hospital is very sensitive when i am asking questions.".
Additional Manufacturer Narrative
Balt usa reference number: (b)(4).Update 26sep2022 - additional information received from the issuer indicated that the patient had an underlying condition (subarachnoid hemorrhage) due to a ruptured aneurysm.Limited information was able to be obtained from the hospital regarding the incident (date of patient death was unable to be obtained) even after multiple follow up attempts were made.It was indicated that the patient had no prior procedures performed, and due to the underlying conditions, the patient "was already a hunt hess grade 4/5.Meaning an 80-90% chance of mortality".The physical eclipse2l was unable to be obtained for investigation, however it was indicated that the patient's anatomy was tortuous.The investigation was performed by supplier balt extrusion.Summary provided as follows: the affected catheter eclipse2l has not been returned to balt extrusion for inspection.This investigation is based on the incident description, the lot history records, and the data gathered during our post-marketing surveillance program for such failures.During our review of the lot history record (lhr) and the manufacturing process of the eclipse2l, we noted that: · the braid, the tube, and the balloon are 100% controlled with a visual inspection during the manufacturing process.· a tightness test of the balloon is also performed on every unit per manufacturing process instruction.· the integrity of the microcatheters is 100% controlled.We did not observe any anomaly that could potentially explain the reported issue.There is no other complaint registered on this lot number to date.The incident description mentioned that the eclipse2l was broken during injection of onyx: "during an onyx case, the balloon fractured and ended up occluding the right ica." we were not able to identify the conditions under which the issue occurred and which manipulations were applied by the physician.However, based on our post-marketing surveillance program, such fractures are likely caused by the embolic agent reflux beyond the catheter's distal extremity during the injection, then unlikely linked to the eclipse2l device.The damages mentioned ("thrombectomy after the balloon fractured.") could assuredly be linked to the device removal attempts following the device jailing which caused his rupture.In conclusion, the reported incident (rupture of the catheter after embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.Manufacturing records complied with specifications, and the product was not available for inspection.A comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.No such increase in the rate of occurrence has been observed.However, this issue will remain subject to continued tracking.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f211100553 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Additional Manufacturer Narrative
Balt usa reference number: (b)(4).Update 13oct2022 - sales representative confirmed that the patient had a ruptured fistula (previously reported as a ruptured aneurysm).Sales representative also confirmed that the eclipse2l was stuck in the onyx and then fractured.Update 26sep2022 - additional information received from the issuer indicated that the patient had an underlying condition (subarachnoid hemorrhage) due to a ruptured aneurysm.Limited information was able to be obtained from the hospital regarding the incident (date of patient death was unable to be obtained) even after multiple follow up attempts were made.It was indicated that the patient had no prior procedures performed, and due to the underlying conditions, the patient "was already a hunt hess grade 4/5.Meaning an (b)(4) chance of mortality".The physical eclipse2l was unable to be obtained for investigation, however it was indicated that the patient's anatomy was tortuous.The investigation was performed by supplier (b)(4).Summary provided as follows: the affected catheter eclipse2l has not been returned to (b)(4) for inspection.This investigation is based on the incident description, the lot history records, and the data gathered during our post-marketing surveillance program for such failures.During our review of the lot history record (lhr) and the manufacturing process of the eclipse2l, we noted that: · the braid, the tube, and the balloon are 100% controlled with a visual inspection during the manufacturing process.· a tightness test of the balloon is also performed on every unit per manufacturing process instruction.· the integrity of the microcatheters is 100% controlled.We did not observe any anomaly that could potentially explain the reported issue.There is no other complaint registered on this lot number to date.The incident description mentioned that the eclipse2l was broken during injection of onyx: "during an onyx case, the balloon fractured and ended up occluding the right ica." we were not able to identify the conditions under which the issue occurred and which manipulations were applied by the physician.However, based on our post-marketing surveillance program, such fractures are likely caused by the embolic agent reflux beyond the catheter's distal extremity during the injection, then unlikely linked to the eclipse2l device.The damages mentioned ("thrombectomy after the balloon fractured.") could assuredly be linked to the device removal attempts following the device jailing which caused his rupture.In conclusion, the reported incident (rupture of the catheter after embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.Manufacturing records complied with specifications, and the product was not available for inspection.A comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.No such increase in the rate of occurrence has been observed.However, this issue will remain subject to continued tracking.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f211100553 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "during an onyx case, the balloon fractured and ended up occluding the right ica." 02aug2022, additional information received from the issuer: "were any additional procedures performed by the physician? thrombectomy after the balloon fractured." 10aug2022 - additional information received from the issuer: "- could you please tell us what was the planned procedure? onyx injection through e2l for a fistula - could you please give us information on patient's status? withdrew care - can you please confirm that there is no patient injury? no - was the patient's anatomy tortuous? yes " 29aug2022 - additional information received from the issuer: "care was withdrawn and patient expired".19sep2022 - additional information received from the issuer: "the underlying condition was a subarachnoid hemorrhage- the patients aneurysm ruptured.As i stated over the phone initially when we spoke the patient was already a hunt hess grade 4/5.Meaning an 80-90% chance of mortality.There were no prior procedures done.Hospital is very sensitive when i am asking questions." 13oct2022 - discussion with sales rep confirmed understanding of the incident: sales representative confirmed that the patient had a ruptured fistula (previously reported as a ruptured aneurysm).Sales representative also confirmed that the eclipse2l was stuck in the onyx and then fractured.

• Brand Name: ECLIPSE2L BALLOON CATHETER
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 15300831
• Report Number: 3014162263-2022-00026
• Device Sequence Number: 14070390
• Product Code: MJN
• UDI-Device Identifier: 00818053023002
• UDI-Public: 00818053023002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: ECL2L6X20
• Device Catalogue Number: N/A
• Device Lot Number: F211100553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 08/01/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown