MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number B2090-040

Device Problems Inflation Problem (1310); Product Quality Problem (1506); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion in an unknown artery.The 9.0x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced for post dilatation of a non-abbott stent, however, the device failed to inflate.After removal, the balloon was noted to be separated.There were no reported adverse patient effects and there was no reported significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported inflation problem, difficult to remove and shaft damage could not be determined.It may be possible that the inflation device was not properly connected, or the shaft was bent or kinked causing the inflation lumen to become blocked.Additionally, the difficulty removing, and shaft damage may be the result of the distal shaft being entrapped within the anatomy; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - device available for eval updated from "yes" to "no".H6 - medical device problem code 1562 was removed.

Event Description

Subsequent to the initially filed report the following information was provided: the procedure was to treat the right iliac artery.The balloon did not completely inflate.Resistance was noted during removal and shaft damage occurred.It was confirmed that no separation occurred.The armada 35 was simply pulled to retrieve the balloon from the anatomy.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12281905
• MDR Text Key: 265200109
• Report Number: 2024168-2021-06856
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155475
• UDI-Public: 08717648155475
• 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
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: B2090-040
• Device Catalogue Number: B2090-040
• Device Lot Number: 00210G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EPIC STENT; EPIC STENT