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

Catalog Number	1012402-08A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2018
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.Evaluation summary: a visual, dimensional and functional inspection was performed on the returned device.The reported difficulty to remove the device from a guide wire was unable to be confirmed as the proxy wire passed through the lumen without any resistance noted.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to remove.Although a conclusive cause for the reported difficulty could not be identified, the noted damages appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous, heavily calcified obtuse marginal artery.During removal of a 1.5x8mm mini trek balloon dilatation catheter, it got stuck on a fielder xt guide wire (gw) and the coating of the core and tip of the gw peeled off inside the guide wire lumen of the balloon catheter.The devices were simply removed as a single unit.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI TREK II OTW 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: 8057335
• Report Number: 2024168-2018-08664
• Device Sequence Number: 1447133
• Product Code: LOX
• UDI-Device Identifier: 08717648180811
• UDI-Public: 08717648180811
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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 Expiration Date: 10/31/2019
• Device Catalogue Number: 1012402-08A
• Device Lot Number: 61111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR