MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012273-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Evaluation is not complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an in-stent restenosis.The 2.75x15 mm trek balloon dilatation catheter (bdc) was advanced without resistance noted and ruptured at 6 atmospheres.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no reported 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 balloon rupture was unable to be confirmed; however, there was a noted tear on the outer member is what likely was perceived as the rupture by the account.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the noted outer member tear appears to be related to operational context.There is no indication of a product quality issue with respect to 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
• MDR Report Key: 9928976
• Report Number: 2024168-2020-03399
• Device Sequence Number: 701885
• Product Code: LOX
• UDI-Device Identifier: 08717648138362
• UDI-Public: 08717648138362
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 07/31/2020
• Device Model Number: 1012273-15
• Device Catalogue Number: 1012273-15
• Device Lot Number: 70829G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60