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

Catalog Number	1012445-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported balloon rupture and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.Attachment: sus voluntary medwatch report mw5069966.
Event or Problem Description
Sus voluntary medwatch report mw5069966 received stating: during procedure, balloon ruptured.No additional information was received.
Additional Manufacturer Narrative
Internal file number -b)(4).Initial reporter sent report to fda.

• 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: 6647063
• Report Number: 2024168-2017-05144
• Device Sequence Number: 13698334
• Product Code: LOX
• UDI-Device Identifier: 08717648151651
• UDI-Public: (01)08717648151651(17)181031(10)51114G1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: 10/31/2018
• Device Catalogue Number: 1012445-15
• Device Lot Number: 51114G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1