MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number	1008189-40
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
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 inspections were performed.The reported difficulty to remove the guide wire was unable to be confirmed.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 determined the reported difficulties appear to be related to circumstances of the procedure.It is likely that the balloon catheter met resistance during advancement over the guide wire with the moderately calcified and moderately tortuosity anatomy and/or due to a buildup of procedural contaminants (blood, contrast) thus causing the device to become stuck on the guide wire resulting in the reported difficulty to remove.The noted tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the device in an opposite direction as the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was performed to treat a lesion with moderate calcification and moderate tortuosity in the left profunda femoris artery.The viatrac plus peripheral dilatation catheter was advanced without issue to the target lesion and was inflated twice to 10 atmospheres.Negative pressure was held for about 30 seconds between each inflation to deflate the balloon.The balloon was fully deflated upon removal; however, during withdrawal of the device there was resistance between the balloon catheter and.014 non-abbott guide wire.The balloon catheter was stuck and could not be retracted.The guide wire lost vessel placement; therefore, both devices were removed together as one unit.The procedure was finished at this point.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8514894
• Report Number: 2024168-2019-02916
• Device Sequence Number: 11264147
• Product Code: LIT
• UDI-Device Identifier: 08717648056840
• UDI-Public: 08717648056840
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 04/15/2019

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: 12/31/2020
• Device Catalogue Number: 1008189-40
• Device Lot Number: 9012961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 50