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

Catalog Number	1012269-06
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.E1 - facility name: (b)(6).
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous proximal right coronary artery.A 1.5x6mm mini trek balloon dilatation catheter was not attempted to be advanced over the guidewire because the guidewire could be inserted but not be advanced in the wire lumen.Another mini trek was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.Return device analysis found that the tip of the catheter was torn.No additional information provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional analysis were performed on the returned device.The reported difficulty advancing the device over the guide wire was not confirmed; however, the reported smashed and torn tip 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 investigation was unable to determine a conclusive cause for the reported difficulty advancing the device over the guide wire; however, the reported smashed and torn tip appears to be related to circumstances of the procedure.Possible factors that may contribute to the difficulty positioning the bdc over the guide wire may include, but not limited to, 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.In this case, a conclusive cause for the reported difficulty could not be determined since the complaint could not be confirmed during return analysis.The reported smashed and torn tip likely resulted from manipulation of the device and/or interaction with an accessory device.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.E1 - facility name: (b)(6).H6: code 2889 was added.
Event or Problem Description
Subsequently, after the device was analyzed it was noted that the tip was torn.It was confirmed the tip became smashed and torn during procedure.No additional information was provided.

• Brand Name: MINI 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: 18519739
• Report Number: 2024168-2024-00880
• Device Sequence Number: 17811535
• Product Code: LOX
• UDI-Device Identifier: 08717648138072
• UDI-Public: 08717648138072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 12/31/2025
• Device Catalogue Number: 1012269-06
• Device Lot Number: 30111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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 Sex: Unknown