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

Model Number 1012451-20

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for investigation.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 protective sheath of the 3.5x20 mm nc trek balloon dilatation catheter (bdc)was difficult to be removed.The bdc was flushed and prepped per usual but the sheath was very tight and came off after a few attempts.An attempt was made to insert a guide wire, but it was unsuccessful.The device never entered the patient.A new, same size nc trek bdc was used to complete the procedure.There was no adverse patient effect or significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty inserting the guide wire could not be confirmed.The reported difficulty removing the protective sheath could not be tested since the protective sheath was not returned for analysis.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath; however, the reported difficulty inserting the guide wire appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9316515
• MDR Text Key: 177673181
• Report Number: 2024168-2019-13509
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 90129G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1