MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012274-20
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left and right renal arteries with mild calcification and mild tortuosity.When the 3.0x20 mm trek balloon dilatation catheter was being removed from the patient, there was resistance with the guide wire and the balloon shredded [peeled] but did not separate from the balloon and the catheter split in the middle portion but was not in two pieces.No material was left in the patient.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the left and right renal arteries with mild calcification and mild tortuosity.When the 3.0x20 mm trek balloon dilatation catheter was being removed from the patient, there was resistance with the guide wire and the balloon shredded and the catheter split in the middle portion but was not in two pieces.No material was left in the patient.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, it was reported that the balloon split up the shaft and did not shred.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 removing the device from the guide wire; however, the reported split/break appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6 - medical device problem code 1454 removed.1528 added.

• Brand Name: TREK RX 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: 18303082
• Report Number: 2024168-2023-13788
• Device Sequence Number: 6278408
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/16/2024

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: 04/30/2026
• Device Catalogue Number: 1012274-20
• Device Lot Number: 30526G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG