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

Catalog Number 1012451-12

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

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).A visual inspection was performed and the reported winged/wrinkled balloon was confirmed.The reported difficulty removing could not be confirmed due to the condition of the balloon.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 similar incidents reported from this lot.It should be noted that the nc trek rx instructions for use states: 60% contrast medium diluted 1:1 with normal saline.Additionally, submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, the use of a 60:40 contrast solution mix and not soaking the device prior to prep do not appear to have contributed to the reported complaint as there were no inflation issues or difficulty advancing or resistance issued reported.The investigation determined the reported/noted difficulties of difficult to remove, winged/wrinkled balloon and bends on the device appear to be related to circumstances of the procedure.It is likely that the balloon was not fully deflated during retraction causing resistance with the distal end of the guiding catheter resulting in the appearance or a winged/wrinkled distal end of the balloon.The noted bends on the device likely occurred post procedure and/or during packing for return analysis.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending coronary artery with no tortuosity and no calcification.A 3.50x12 mm nc trek rx balloon dilatation catheter (bdc) was prepped (air aspirated) outside of the anatomy prior to use; however, the balloon was not soaked.The contrast ratio was 60:40.The bdc was advanced to the lesion for post dilatation of an unspecified stent.Post deflation, the balloon would not rewrap [refold] tightly and the bdc met resistance with an unspecified guide catheter on removal.The guide catheter, bdc and an unspecified guidewire were removed together as a single unit.The procedure was successfully completed with placement of a 5f diagnostic sheath for post stent imaging.There were no adverse patient effects and no clinically significant delay in the procedure.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: 7857642
• MDR Text Key: 119653350
• Report Number: 2024168-2018-06978
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012451-12
• Device Lot Number: 80416G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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