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

Catalog Number	1012270-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The investigation was unable to determine a conclusive cause for the reported balloon rupture.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue.
Event or Problem Description
It was reported that the procedure was to treat a coronary lesion located in the posterior descending artery that was mildly calcified and mildly tortuous.When the mini trek 2.0 x 8.0 mm balloon dilatation catheter (bdc) was pressurized for the first time at 5 atmospheres, the balloon inflated, but it kept losing pressure.The device was prepped according to the instructions for use.The device was removed and replaced with another same size mini trek bdc.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI 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: 5922734
• Report Number: 2024168-2016-05877
• Device Sequence Number: 19189001
• Product Code: LOX
• UDI-Device Identifier: 08717648138133
• UDI-Public: (01)08717648138133
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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
• Report Date (Section B): 09/01/2016

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 Catalogue Number: 1012270-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1