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

Catalog Number	1012448-20
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2016
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 was received.Investigation is not complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during device preparation, the 2.75x20 mm nc trek rx balloon dilatation catheter was removed without resistance from the hoop, and the mid-shaft separated.The device was not used and there was no patient involvement.There was no clinically significant delay in the intended procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported separation 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 similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported shaft separation.

• 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: 6080584
• Report Number: 2024168-2016-07622
• Device Sequence Number: 731723
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: (01)08717648151835(17)190630(10)60716G1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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: 06/30/2019
• Device Catalogue Number: 1012448-20
• Device Lot Number: 60716G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1