MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a mid right coronary artery that was 95% stenosed.The 3.5x20mm rx trek balloon dilatation catheter (bdc) was advanced to the target lesion with a non-abbott guide extension.Two inflations were performed without issue, the first inflation at 16 atmospheres (atm) for 14 seconds, and the second inflation at 12 atms for 8 seconds.The balloon was then fully deflated without issue.A slight resistance was felt during retrieval of the bdc.The physician was not sure what the bdc had resistance with.It was then observed under flouroscopy that the shaft was coming back without the balloon.Therefore, the guide extension was advanced over the balloon to be pull everything out as a single unit.The detached balloon was never loose in the patient and was retrieved through the guide extension.The procedure ended at this point as the target lesion was treated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.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 did not indicate a lot specific quality issue.As 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.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: 10422433
• Report Number: 2024168-2020-06875
• Device Sequence Number: 2726998
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/21/2020

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: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 91002G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER GUIDE EXTENSION
• Patient Age: 65 YR
• Patient Weight: 109