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

Catalog Number	1012448-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
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.Date of occurrence is estimated.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the 2.75 x 8 mm nc trek dilatation was noted to be kinked.There was no adverse patient effect reported and no clinically significant delay.No additional information was provided.Returned device analysis noted that the inner member was separated at the proximal balloon marker, but the outer member remained intact.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular identified that the proximal seal was stretched and the inner member had a separation at the proximal balloon marker.It is likely that the account perceived the stretched proximal seal/inner member separation as the kink.The analysis of the returned device suggests that the stretching/separation may be related to tensile overload when removing the protective sheath.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the devices performance with regard to the difficulty removing the protective sheath appear to be related to normal variation found in manufacturing.There was no indication of a product quality issue.The performance of these devices will continue to be monitored.

• 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: 6368500
• Report Number: 2024168-2017-01666
• Device Sequence Number: 10771615
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: (01)08717648151804(17)180331(10)50416G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 03/31/2018
• Device Catalogue Number: 1012448-08
• Device Lot Number: 50416G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1