MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X9
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference #(b)(4).Investigation results pending return of the suspected device, followed by analysis from supplier, balt extrusion.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: "procedure (b)(6) 2022 dav fistuala.Inflated ballon in middle meningeal artery.Achieved embolization.There was 1cm for reflux.Deflated balloon, and tried to remove it from onyx cast.Felt a stretching.When catheter was removed from the catheter, it was stretched.The tip appeared to be missing.Patient appears to be fine".
Additional Manufacturer Narrative
Balt usa reference (b)(4).The device analysis was performed by supplier balt extrusion.Summary as follows: the affected device ecl2l 6x9 has been returned and inspected in our quality laboratory.During our analysis, we noticed that the catheter was ruptured, and the braid of the catheter was severely stretched/damaged.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.· the integrity of the microcatheters is 100% controlled.We did not observe any anomaly that could potentially explain the reported issue.The incident description mentioned that the eclipse2l was entrapped into the injected embolic agent: "deflated balloon, and tried to remove it from onyx cast".We were not able to identify the conditions under which the issue occurred, and which manipulations were applied by the physician.However, according to our post-market surveillance program and the incident description " there was 1cm for reflux.", such blockages 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 incident description mentioned also that the eclipse2l was broken "when catheter was removed from the catheter, it was stretched.The tip appeared to be missing.".This damage results of an excessive strength applied during removing of the catheter.As mentioned in the instruction for use (ifu), it is necessary to follow the recommendations during the removal of the catheter " avoid advancing or withdrawal against resistance before the cause of resistance is determined".In conclusion, the incident reported (embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.The investigation of the product affected did not reveal any non-conformity which could be due to the manufacturing process, the most probable cause due to this incident is an embolic agent reflux.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 f220701267 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: "procedure (b)(6) 2022 dav fistuala.Inflated ballon in middle meningeal artery.Achieved embolization.There was 1cm for reflux.Deflated balloon, and tried to remove it from onyx cast.Felt a stretching.When catheter was removed from the catheter, it was stretched.The tip appeared to be missing.Patient appears to be fine" incident report form received for this event indicated that there was no patient injury.

• 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: 15890050
• Report Number: 3014162263-2022-00039
• Device Sequence Number: 5218586
• Product Code: MJN
• UDI-Device Identifier: 00818053022944
• UDI-Public: 00818053022944
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: ECL2L6X9
• Device Catalogue Number: N/A
• Device Lot Number: F220701267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2022
• 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: Other
• Patient Sex: Unknown