MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number	1012405-20
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual, dimensional and functional inspections were performed.The reported difficulty to position the balloon catheter over a guide wire was unable to be confirmed due to the returned condition of the device and wire.The reported difficulty to remove was confirmed.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 identified no other similar incidents from this lot.Factors that may contribute to the difficulty to position and removing the balloon catheter over the guide wire and cause resistance between the devices may include, but not limited to, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, buildup of blood or contrast, or damage to the balloon catheter.The investigation determined the reported/noted difficulty to position, to remove, shaft kinks and bunching appear to be related to circumstances of the procedure.Based on the reported information and the returned analysis, it is likely inadvertent mishandling of the device during preparation or during loading of the wire the device became kinked at multiple locations likely resulting in resistance and the difficulty to position the wire.Additional manipulation of the wire and device likely caused the inner/outer member (shaft) to bunch locking the wire in place.The distal end of the wire was able to able to advance 10.5cm past the distal tip of the balloon catheter without issue, which also suggests that the device was advancing as intended prior to the shaft bunching.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient presented with a st-elevated myocardial infarction (stemi) and a mid right coronary artery (rca) lesion.During placement of a trek coronary dilatation catheter over a non-abbott guide wire, the trek dilatation catheter became stuck with the wire.The catheter was unable to be removed from the wire so all was removed as a single unit.The patient was re-wired and a xience stent was successfully implanted.There were no adverse patient effects and there was no clinically significant delay noted.No additional information was provided regarding this issue.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8302635
• Report Number: 2024168-2019-00805
• Device Sequence Number: 1589543
• Product Code: LOX
• UDI-Device Identifier: 08717648153990
• UDI-Public: 08717648153990
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 06/30/2021
• Device Catalogue Number: 1012405-20
• Device Lot Number: 80730G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/04/2019
• 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: GUIDE WIRE: COUGAR
• Patient Age: 84 YR