MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012452-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 before use, the protective sheath could not be removed from the 3.75x15 mm nc trek balloon dilatation catheter (bdc).The device was not used and there was no patient involvement.A new, same size nc trek was used to complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.Visual and functional inspections/tests were performed.The difficulty to remove the sheath was not 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8092647
• Report Number: 2024168-2018-08987
• Device Sequence Number: 1359093
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: 08717648152030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 02/28/2021
• Device Catalogue Number: 1012452-15
• Device Lot Number: 80314G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1