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

Catalog Number 1013155-12

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the u.S.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified, 90% stenosed, mid right coronary artery.The patient was experiencing an acute myocardial infarction.After thrombectomy and pre-dilatation was performed, a 3.5 x 33 mm xience prime stent was deployed in the lesion at 14 atmospheres.Post-dilatation was being performed with a 3.5 x 12 mm nc traveler balloon catheter; however, after balloon deflation the balloon would not refold.The balloon was able to be removed deflated with some resistance noted but without patient effects.A non-abbott nc balloon was used to complete post-dilatation.No adverse patient effects were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and pressurized to 18 atms and after applying negative pressure, the balloon would not deflate.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.An expanded investigation determined the difficulty in deflating the balloon may possibly be related to manufacturing.This appears to be an isolated issue that will be addressed per standard operating procedures.These devices will continue to be monitored.

Event Description

Subsequent to the previously filed medwatch report, additional informtion received as follows: the balloon would not deflate at all prior to the attempted removal of the balloon catheter from the stent implant.No additional information was provided.

• Brand Name: NC TRAVELER 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: 5381691
• MDR Text Key: 36626393
• Report Number: 2024168-2016-00380
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/20/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 1013155-12
• Device Lot Number: 40901G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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