MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012272-20
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.The 2.50x20 mm trek balloon dilatation catheter (bdc) was being loaded onto a non-abbott guide wire when the balloon buckled and separated from the shaft of the catheter.The guide wire would not advance any further.The trek bdc was prepped per the ifu but the lab tech could not recall if the guide wire had been wiped with wet saline.The balloon did not enter the patient anatomy.A new trek bdc was used to complete the procedure.The patient was treated successfully and eventually stented with a 2.75mm x 28mm xience skypoint stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported kink was confirmed; however, the reported difficulty advancing the device onto the guide wire and separation were not 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 investigation was unable to determine a conclusive cause for the reported difficulty advancing the device onto the guide wire.However, factors that may contribute to the difficulty positioning the bdc over the guide wire may include, but not limited to, manufacturing damage, device placement technique, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.The reported kink appears to be related to circumstances of the procedure as it is likely that handling of the device during attempts to advance it over the guide wire with resistance, likely resulted in the shaft kinking.Return analysis was unable to confirm the reported separation and thus a conclusive cause could not be determined.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: 13792296
• Report Number: 2024168-2022-02722
• Device Sequence Number: 1714506
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: 08717648138300
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: 09/30/2024
• Device Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 11009G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LUGE GUIDE WIRE
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG