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	12/26/2017
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.(b)(4).The device was not returned for evaluation.It was reported that the mini trek rx balloon dilatation catheter was advanced into a dislodged stent and inflated.It should be noted that the instructions for use (ifu) states: the mini trek rx coronary dilatation catheter is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion, or balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc trek is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the distal circumflex artery.A non-abbott stent had dislodged during use in the patient.The 2.0 x 8 mm mini trek was advanced through the dislodged stent and inflated; however, the balloon ruptured at an unknown atmosphere.The 2.5 x 8 mm nc trek balloon was advanced through the stent implant and inflated, the balloon was used to move the dislodged stent from the circumflex to the left main successfully.The balloon then ruptured at an unknown pressure and during retraction from the patient resistance was felt and the balloon itself separated from the catheter shaft.A snare device was used to capture the separated balloon and the dislodged stent from the patient successfully.The procedure continued on successfully with the placement of a xience alpine stent.No adverse patient effects of clinically significant delay in the procedure were reported.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: 7202280
• Report Number: 2024168-2018-00447
• Device Sequence Number: 16173824
• Product Code: LOX
• UDI-Device Identifier: 08717648138133
• UDI-Public: 08717648138133
• 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): 01/17/2018

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: 01/02/2018
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR