MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012275-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat an unknown lesion.The rx trek balloon dilatation catheter (bdc) was inflated to 8 atmospheres (atm) when the balloon ruptured.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed medwatch, additional information was received.It was reported the procedure was to treat a mildly tortuous and calcified lesion in the right coronary artery (rca).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 determined the reported balloon rupture 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.

• 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: 9967221
• Report Number: 2024168-2020-03688
• Device Sequence Number: 4483649
• Product Code: LOX
• UDI-Device Identifier: 08717648138508
• UDI-Public: 08717648138508
• 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): 05/22/2020

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: 01/31/2022
• Device Model Number: 1012275-15
• Device Catalogue Number: 1012275-15
• Device Lot Number: 90204G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1