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

Catalog Number 1008193-30

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other two 5 x 30 mm rx viatrac plus devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the part number on the international label (b)(6) on the boxes of three 5 x 30 mm rx viatrac plus peripheral dilatation catheters did not match the part number on the english label.The label discrepancy was noted at the distribution center.The dilation catheters were not used.There was no patient involvement.No additional information was provided.

Event Description

Clarification: the label discrepancy was noted at the distributor in (b)(6).

Manufacturer Narrative

(b)(4).The device was returned for analysis and the labeling discrepancy was confirmed.The investigation determined the labeling issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8029934
• MDR Text Key: 125910702
• Report Number: 2024168-2018-08360
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648056994
• UDI-Public: 08717648056994
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1008193-30
• Device Lot Number: 8081061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2018
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1