MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-15
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with mild calcification and mild tortuosity.The 5.00x15mm trek balloon dilation catheter (bdc) was attempted to be loaded onto a non-abbott guidewire (gw); however, the tip of the bdc was not open.Therefore the gw was not able to be inserted into the bdc.The bdc was not used in the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another trek was used to continue the procedure.Device return analysis found a hole in the inner member proximal from the proximal seal of the balloon.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned device.The reported difficulty inserting the device could not be replicated in a testing environment due to the condition of the returned device.It was noted that there was a hole in the inner member proximal from the proximal seal.The reported material deformation could not be confirmed; however, it is likely that the account perceived the tip as the distal side of the bdc as damage was noted during return analysis.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.There was no damage noted to the device during the inspection prior to use which or leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Return analysis noted a hole in the inner member proximal from the proximal seal.In this case, it is likely that the guide wire was backloaded incorrectly and/or at an angle such that the guide wire punctured the inner member resulting in the reported difficulty inserting the device and giving the impression of the tip of the bdc not being open (by tip it¿s likely that they mean the distal side of the bdc).The investigation determined the reported complaints appear 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.

• 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: 15749484
• Report Number: 2024168-2022-11326
• Device Sequence Number: 6241669
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 11/07/2022

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: 10/31/2024
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 11125G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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