MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Model Number	1012403-08A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported during preparation of the 2.0x8mm mini trek balloon dilatation catheter (bdc) the balloon ruptured at 8 atmospheres.The device was not used and another balloon was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and scanning electron microscopy (sem) inspection/analysis was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the balloon rupture may possibly be related to exposure conditions or a material/processing discrepancy.The balloon failure initiated within the material thickness.Wall thinning, peeling/delamination and tearing was observed.The rupture origin area was in the vicinity of the proximal marker.No evidence of severe mechanical damage associated with the failure was observed.The investigation determined a potential product quality issue based on the reported balloon rupture, noted longitudinal balloon rupture, and multiple scratches and peeling materials noted on the balloon during return analysis.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14250694
• Report Number: 2024168-2022-04650
• Device Sequence Number: 4445216
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: 08717648180866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 07/31/2024
• Device Model Number: 1012403-08A
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 10827G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Patient Sex: Unknown