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

Catalog Number	1012271-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was not confirmed.There was no report of any damage noted to the balloon dilatation catheter (bdc) during preparation prior to use, which suggests that a product quality issue did not contribute to the reported complaint.In this case, a conclusive cause for the reported deflation issue could not be determined as the reported complaint could not be confirmed during return analysis.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.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported procedure was to treat a lesion in the right coronary artery.The 2.25x12 mm trek rx balloon was inflated once just over 8 atmospheres, but negative pressure was held many times and the balloon did not completely deflate.The trek rx catheter was removed with the balloon partially inflated; however no resistance was felt during removal.The procedure was completed with an unspecified alpine stent delivery system.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 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: 6254462
• Report Number: 2024168-2017-00486
• Device Sequence Number: 830812
• Product Code: LOX
• UDI-Device Identifier: 08717648138218
• UDI-Public: (01)08717648138218(17)181130(10)51214G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/16/2017

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: 11/30/2018
• Device Catalogue Number: 1012271-12
• Device Lot Number: 51214G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1