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

Model Number	1012451-20
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9316515
• Report Number: 2024168-2019-13509
• Device Sequence Number: 16737607
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1