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

Model Number	1012447-08
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that before use of a 2.5x8mm nc trek balloon, it was not possible to remove the protective sheath.The device was not used and there was no patient involvement.A new balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the protective sheath was confirmed.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.

• Brand Name: NC TREK RX & VOYAGER NC
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9819564
• Report Number: 2024168-2020-02273
• Device Sequence Number: 1568309
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 05/31/2021
• Device Model Number: 1012447-08
• Device Catalogue Number: 1012447-08
• Device Lot Number: 80622G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1