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

Catalog Number 1012451-25

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.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 an unknown lesion.After the nc trek rx 3.50 x 25 mm balloon dilatation catheter was advanced to the lesion, but before inflation, it was noticed that there were no radiopaque markers on the balloon.This was confirmed with fluoroscopy after removing the device from the patient.The patient was alternatively treated via percutaneous transluminal medical intervention.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The reported missing balloon markers could not be confirmed as the distal portion of the device was not returned.It was reported that the balloon markers were missing on the device and during follow up the account confirmed that no balloon separation was noted.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.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 was unable to determine a conclusive cause for the reported missing component (markers).There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequently to the previously filed medwatch report, the following additional information was received: there was no resistance during removal of the protective sheath and the device was prepped according to the instructions for use.Physician stated when advancing the nc trek rx in the anatomy he realized there were no radiopaque marks.He removed the balloon under fluoroscopy and he confirmed there were no radiopaque marks.No balloon separation was noted.The device was confirmed to be loaded on the guide wire without any complications.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: 6760188
• MDR Text Key: 81795313
• Report Number: 2024168-2017-06338
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1012451-25
• Device Lot Number: 60111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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