MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-20
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary intervention, the 4.00 x 20mm trek balloon dilatation catheter was advanced to the lesion.Upon inflation of the balloon, it was noted that inflation was slow before reaching nominal pressure, so the device was attempted to be removed; however, resistance was noted with the 0.014 guide wire, so both devices were removed as a single unit.Once removed, a leak was observed at the junction with the monorail guiding catheter.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another unspecified device was used to continue the procedure.No additional information was provided.
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.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported leak and inflation issue were confirmed; however, the reported difficulty removing the device from the guide wire could not be confirmed.Return analysis noted the guidewire exit notch was torn, stretched and the material was lifted on the distal end.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 investigation was unable to determine a conclusive cause for the reported inflation issue, difficulty removing the device from the guide wire or leak.Possible factors that may contribute to difficulty inflating the balloon may include, but are not limited to, manufacturing, poor connection with the inflation device, damage to the guide wire and/or inflation lumen, patient anatomical morphology, and patient disease state.Additionally, possible factors that may contribute to difficult removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.There was no damage noted to the balloon catheter prior to use or leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.The tearing of the guide wire exit notch could possibly have resulted from an interaction with the guide wire and/or mandrel/stylet.This type of mechanical damage can occur if an attempt is made to pull the catheter in an opposite direction as the guide wire or the mandrel/stylet is mishandled during removal.In this case, it is possible that the noted tear in the guide wire exit notch resulted in the reported leak and possible inflation issue; however, it is unknown when these damages occurred.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK CORONARY DILATATION CATHETER
• 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: 14598510
• Report Number: 2024168-2022-05964
• Device Sequence Number: 5541464
• Product Code: LOX
• UDI-Device Identifier: 08717648138720
• UDI-Public: 08717648138720
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 06/30/2023
• Device Model Number: 1012278-20
• Device Catalogue Number: 1012278-20
• Device Lot Number: 00713G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 GUIDE WIRE; MONORAIL GUIDING CATHETER
• Patient Age: 65 YR
• Patient Sex: Unknown