MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B1050-020

Device Problems Inflation Problem (1310); Leak/Splash (1354); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that this was a percutaneous intervention, treating a de novo lesion within an arterial-venous shunt.During use of the armada dilatation catheter, contrast was observed leaking from the base of the catheter shaft.Another armada was used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

Event Description

Subsequent to the previously filed report, additional information was provided: during preparation and while applying negative to the armada balloon, it felt strange (the pressure was not felt).While attempting to inflate the balloon in the anatomy, the balloon would not hold pressure and failed to inflate.Leaking was then noted at the hub.

Manufacturer Narrative

Device codes: 1310 labeled 3190 labeled na.Internal file number - (b)(4).Evaluation summary: a visual and functional inspections were performed on the returned device and the reported difficulties were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Based on review of the similar incidents, there is an indication of a lot specific issue.The investigation determined the reported leak 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: ARMADA 35 PTA 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: 8224240
• MDR Text Key: 132345262
• Report Number: 2024168-2019-00143
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: B1050-020
• Device Lot Number: 60225G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1