MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012272-08
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not reported as returning.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Sus voluntary event report ((b)(4)) received which states: while trying to reinsert 2.5 x 8 trek ptca balloon, the shaft broke and made the device unusable.Balloon was not in patient at that time but on the wire only.Fda safety report id# (b)(4).
Additional Manufacturer Narrative
This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.User facility medwatch attached: mw 5094546na - attachment: [cn-034558.Pdf].
Additional Manufacturer Narrative
The device was not returned for 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 incidents from this lot.There was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10156105
• Report Number: 2024168-2020-05059
• Device Sequence Number: 19629423
• Product Code: LOX
• UDI-Device Identifier: 08717648138270
• UDI-Public: 08717648138270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 09/30/2022
• Device Model Number: 1012272-08
• Device Catalogue Number: 1012272-08
• Device Lot Number: 91008G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 07/20/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/10/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1