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

Catalog Number	1012280-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
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.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.It should be noted that the coronary dilatation catheters (cdc), trek rx instructions for use states: prior to use, examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.The investigation determined the reported kink appears to be related operational context; however, the reported separation appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous saphenous vein graft.A 5.0 x 15 mm trek balloon catheter was used.The device was being advanced over an unspecified guide wire that was inside the anatomy, and did not meet any resistance during advancement.However, it was noted that the shaft of the device may have been kinked before loading onto the guide wire.The hypotube then separated from the device outside the anatomy; therefore, the device was simply pulled out.An unspecified balloon catheter was then used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 6975020
• Report Number: 2024168-2017-08436
• Device Sequence Number: 13826849
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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 Catalogue Number: 1012280-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR