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

Model Number	1012275-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 to treat a heavily calcified and moderately tortuous lesion in the mid to distal left anterior descending (lad) artery.The 3.25x20mm rx trek balloon dilatation catheter (bdc) was advanced however failed to cross the lesion multiple times and the proximal shaft outside the anatomy separated.The device was simply removed from the patient with the guiding catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the reported separation was confirmed.The reported failure to advance and difficulty to remove were unable to be replicated in a testing environment as it was based on operational circumstances.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 reported from this lot.The investigation determined the reported separation, failure to advance and difficult to remove appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
Subsequent to the initially filed medwatch report, it was reported resistance was met during retraction of the rx trek.No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9632904
• Report Number: 2024168-2020-00909
• Device Sequence Number: 2800275
• Product Code: LOX
• UDI-Device Identifier: 08717648138515
• UDI-Public: 08717648138515
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/03/2020

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: 1012275-20
• Device Catalogue Number: 1012275-20
• Device Lot Number: 90202G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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: GUIDING CATHETER
• Patient Age: 69 YR
• Patient Weight: 109