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

Model Number 1012455-08

Device Problems Deflation Problem (1149); Difficult to Insert (1316); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

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.Na.

Event Description

It was reported that a 5.0x8mm nc trek was inflated; however, after use there was a failed attempt to insert the catheter into an unspecified guide catheter for removal because the balloon did not properly deflate.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Event Description

It was reported that a 5.0x8mm nc trek was inflated; however, after use there was a failed attempt to insert the catheter into an unspecified guide catheter for removal because the balloon did not properly deflate.There was no adverse patient effect and no clinically significant delay.Additional information was received that the nc trek met resistance during advancement with an unspecified 7fr guide catheter.The device did deflate; however, deflation was slow.No other device was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed.The reported difficulty advancing and removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty advancing and removing the device from the guiding catheter appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6: code 1316 (difficult to insert) was removed.H6: code 1528 (difficult to remove) and 2920 (difficult to advance) were added.

• 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: 11732677
• MDR Text Key: 247689386
• Report Number: 2024168-2021-03557
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 00828G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1