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

Catalog Number	1012402-15A
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2018
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.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guidewire due to a buildup of procedural contaminates (blood, contrast) on the guide wire resulting in the reported difficulty to advance and remove the bdc.Additional movement of the catheter against resistance likely resulted in the devices becoming stuck together.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The unspecified mini trek otw device is being filed under a separate medwatch report #.
Event or Problem Description
It was reported that the procedure was performed to treat a re-stenosed lesion in the proximal diagonal coronary artery with moderate tortuosity and heavy calcification.An unspecified mini trek otw balloon dilatation catheter (bdc) was advanced however failed to cross the lesion as it met resistance with an unspecified guide wire.The bdc was unable to be removed independently and therefore the bdc and guide wire were removed together as a single unit.Following re-wiring with an new unspecified guide wire, a 1.50 x 15 mm mini trek ii otw balloon dilatation catheter (bdc) was advanced; however the same problem occurred.A non-abbott bdc was used to complete the procedure.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: 8233660
• Report Number: 2024168-2019-00250
• Device Sequence Number: 13925122
• Product Code: LOX
• UDI-Device Identifier: 08717648180835
• UDI-Public: 08717648180835
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/09/2019

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: 08/31/2021
• Device Catalogue Number: 1012402-15A
• Device Lot Number: 80920G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 112