MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number 1012449-12

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

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

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 during preparation of a 3.0x12mm nc trek balloon dilatation catheter (bdc) difficulty removing the protective sheath was felt.The protective sheath was able to be removed; however, the bdc was not used and there was no patient involvement.The procedure was successfully completed with an unspecified balloon catheter.No additional information was provided.

Manufacturer Narrative

H6: device coding: 2017 - incorrect prep.Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the protective sheath was confirmed.It should be noted that the coronary dilatation catheters nc trek rx, global, instructions for use (ifu) states: complete the following steps to prepare the nc trek rx coronary dilatation catheter for use: slide the protective sheath off the balloon prior to performing air aspiration.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D4: lot# and expiration date h4: device mfg date.

Event Description

Additional information: the 3.0x12mm nc trek catheter was prepared prior to removing the protective sheath.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10017592
• MDR Text Key: 189650499
• Report Number: 2024168-2020-04039
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151866
• UDI-Public: 08717648151866
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1012449-12
• Device Catalogue Number: 1012449-12
• Device Lot Number: 91219G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1