MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X12
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "dr.(b)(6) was doing an onyx embo of a mma.He was using a 6x12 eclipse in a sub 2mm vessel.He went to remove the balloon and it was stuck in the cast.After several attempts and stretching of the catheter the eclipse balloon fractured leaving a portion of the balloon and catheter behind.Dr.Stone performed an endarterectomy to remove the catheter and balloon from the carotid artery.He was able to retrieve all of the balloon and catheter.".
Additional Manufacturer Narrative
Balt usa reference: # (b)(4).The product was not available for analysis.Supplier balt extrusion provided their investigation of the reported issue, 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 device 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.By correlating this information with our post-marketing surveillance program, such blockages are generally 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 that the eclipse2l was entrapped into the injected embolic agent: "he went to remove the balloon, and it was stuck in the cast").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 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.Unable to identify the conditions under which the damages mentioned ("patient was taken to surgery for endarterectomy to remove the balloon from the carotid artery.") could assuredly be linked to the device removal attempts following the device jailing.In conclusion, the incident reported (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.

• 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: 14685739
• Report Number: 3014162263-2022-00016
• Device Sequence Number: 4818318
• Product Code: MJN
• UDI-Device Identifier: 00818053022968
• UDI-Public: 00818053022968
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: ECL2L6X12
• Device Catalogue Number: N/A
• Device Lot Number: F220300836
• 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: 05/16/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: Required Intervention
• Patient Sex: Unknown