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

Catalog Number 1012451-15

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported resistance with the balloon catheter could not be replicated in a testing environment as it was based on operational circumstances.It was reported that force was used, which resulted in the shaft separating.It should be noted coronary dilatation catheters, nc trek rx, instruction for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported separation and resistance with the balloon catheter appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a patient that presented with an acute st myocardial infarction.The lesion was located in the narrow and concentric left anterior descending artery.A kissing balloon technique was being used.When the 3.5 x 15 mm mini trek balloon was advanced it met resistance with the other balloon catheter, force was used, which resulted in the proximal shaft separating.The separated device was removed from the patient without issue or adverse patient effects.The first balloon catheter was left in place and another balloon catheter was used successfully with this same balloon to complete the case without further issue.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
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6300346
• MDR Text Key: 66719383
• Report Number: 2024168-2017-00919
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: (01)08717648151989(17)190831(10)60913G1
• 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: 02/03/2017

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: 08/31/2019
• Device Catalogue Number: 1012451-15
• Device Lot Number: 60913G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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