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

Catalog Number	1012448-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that prior to use, the protective sheath was able to be removed from the nc trek, but with resistance.The nc trek was inserted to post dilate a 2.75x38 xience alpine stent in the 99% stenosed, heavily calcified lesion in the left circumflex coronary artery.The nc trek reached the lesion, but would not inflate when the inflation device was taken to 10 atmospheres.The nc trek was removed from the anatomy and tested by the doctor on the back table.The doctor noted that the nc trek began to inflate after the inflation device was taken to 10 atmospheres.Another nc trek was successfully used to 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
(b)(4).Evaluation summary: the device was returned for analysis and although the protective sheath was not returned, abbott vascular (av) identified stretching near the proximal balloon seal, which is indicative of the reported difficulty removing the protective sheath.The difficulties inflating the device could not be confirmed as the inflation times met the specification.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 regards to the difficulty with removing the protective sheath appears 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: 5914648
• Report Number: 2024168-2016-05808
• Device Sequence Number: 467605
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: (01)08717648151835(17)181130(10)51211G1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/13/2017

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: 11/30/2018
• Device Catalogue Number: 1012448-20
• Device Lot Number: 51211G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2016
• 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
• Patient Age: 86 YR
• Patient Weight: 82