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

Catalog Number	1012452-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
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 2.0 x 15 mm mini trek referenced, is being filed under a separate medwatch report #.Evaluation summary: visual and functional inspections were performed on the returned device.The reported folded (bunched balloon) was confirmed; however, the reported difficulty removing the device from the rotating hemostatic valve (rhv) could not be replicated in a testing environment due to the condition of the returned device.It should be noted nc trek rx coronary dilatation catheters instruction for use (ifu) states: balloon pressure should not exceed the rbp.In this case, it is unknown if the reported violation of the ifu caused or contributed to the complaint.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 from this lot.The investigation determined the reported difficulties appears 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 saphenous vein graft to the diagonal.The 2.0 x 15 mm mini trek balloon catheter was used for treatment of a lesion in the mid diagonal artery.The 3.75 x 20 mm nc trek balloon catheter was used for treatment of a de novo lesion located in the moderately tortuous, distal diagonal artery and was inflated to 20 atmospheres.There was no difficulty experienced during deflation of the balloons; however, during retraction after use, both balloons met resistance during removal through the y connector; however, were able to be successfully removed.The balloons appeared to be "bunched up";.Both balloons were confirmed to be fully deflated prior to removal through the y-connector.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• Brand Name: NC 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: 6978373
• Report Number: 2024168-2017-08485
• Device Sequence Number: 16450880
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: 08717648152047
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 04/30/2020
• Device Catalogue Number: 1012452-20
• Device Lot Number: 70502G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1