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

Catalog Number	1012273-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guide wire: fielder, xt-r, guide catheter: launcher6fr ebu3.5, guideliner.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 of the reported lot did not indicate a lot specific quality issue.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 respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 99% stenosed, moderately tortuous, and heavily calcified lesion in the mid left anterior descending artery.Following pre-dilatation with a non-abbott balloon, a 2.75x15mm trek rx balloon dilatation catheter met resistance with the lesion during advancement.Once at the lesion site the balloon ruptured during first inflation at 12 atmospheres.The procedure was successfully completed with a 2.75x15mm non-abbott balloon catheter and non-abbott stent.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: 6538974
• Report Number: 2024168-2017-03825
• Device Sequence Number: 749519
• Product Code: LOX
• UDI-Device Identifier: 08717648138362
• UDI-Public: (01)08717648138362(17)180731(10)50810G1
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2017

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 Expiration Date: 07/31/2018
• Device Catalogue Number: 1012273-15
• Device Lot Number: 50810G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR