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

Catalog Number 1012455-12

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.Investigation is not yet complete.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The versaturn guide wire referenced is filed under a separate medwatch manufacturer report reference number.

Event Description

It was reported that the procedure was to treat a heavily restenosed non-abbott stent located in the heavily calcified proximal left circumflex (cx) artery.The lesion was a chronic total occlusion (cto).Additionally, there was a lesion located in the proximal left anterior descending artery; therefore, both vessels were wired.One xience alpine stent was deployed in the ostium of the cx.Another xience alpine stent was deployed in the proximal lad to the left main (bifurcation trousers technique).After deployment of the second xience alpine stent, it was observed that upon removal of the versaturn guide wire, the guide wire was broken, but not in two pieces, and was able to be removed from the patient without issue.The nc trek balloon catheter was advanced for post-dilatation of the overlapping stents.After negative pressure was applied, fully deflating the balloon, during retraction of the balloon catheter, the balloon appeared to be stuck on the other unspecified guide wire and could not be advanced or retrieved.The decision was made to remove the remaining guide wire and the balloon catheter together as a single unit.The lesion was rewired to continue the procedure using a new balloon catheter.No adverse patient effects were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported resistance felt with difficulty to remove and difficulty to position issues could not be confirmed.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties.The additional versaturn guide wire, referenced is filed under a separate medwatch manufacturer report number.

Event Description

Returned device analysis confirmed that the guide wire returned inside the nc trek balloon catheter was a versaturn guide wire.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5698121
• MDR Text Key: 46621054
• Report Number: 2024168-2016-03575
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1012455-12
• Device Lot Number: 50817G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR