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

Catalog Number 1012454-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported winged balloon and difficulty removing the device from the guiding catheter were 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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

Event Description

It was reported that the patient underwent a coronary procedure was to treat restenosis in an unspecified stent.The 4.5 x 15 mm nc trek dilatation catheter was advanced to the target lesion and inflated without issue.The balloon was then deflated and appeared fully deflated on angiography.An attempt was made to remove the device; however, resistance was felt and the device would not enter the guide catheter.The devices were removed as a single unit.Upon removal, the nc trek balloon was noted to be winged.There was no adverse patient effect and no clinically significant delay.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: 6351725
• MDR Text Key: 68280629
• Report Number: 2024168-2017-01456
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: (01)08717648152115(17)190930(10)61024G1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/22/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012454-15
• Device Lot Number: 61024G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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: 70 YR