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

Catalog Number B1070-040

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the iliac artery.The armada balloon was advanced into the 6f introducer, but when the physician wanted to remove it, force was applied, and the balloon catheter was damaged.The introducer and the balloon were removed together.There was no reported adverse patient effect or a clinically significant delay.No additional information was provided.

Manufacturer Narrative

Device codes: 1506 labeled.Internal file number - (b)(4).Correction: event description.Device codes 1546 - labeled, 2920 - labeled - removed.The investigation determined that the reported difficulties were due case circumstances.It is likely that during deflation, the balloon did not properly refold and/or was not fully deflated causing the reported difficulty to remove from the introducer sheath.The reported force during retraction against resistance and ultimately resulted in the unknown damage to the balloon catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the follow-up #1 medwatch report, the following information was received: there was no balloon rupture.After successful use, the balloon catheter was difficult to remove and as force was applied to extract the balloon, the catheter became damaged.There were no reported adverse patient effect or clinically significant delay.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, resistance, with the anatomy, was noted during device advancement.Once at the lesion, the balloon ruptured during the first inflation at nominal pressure.No additional information was provided.

Manufacturer Narrative

Device codes: 1546 labeled 2920 labeled.Internal file number - (b)(4).If follow-up what type correction: device code 3008-labeled - removed.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.It is likely that the balloon interacted with lesion calcification or associated devices causing the reported resistance during advancement and balloon rupture.The difficulty removing was likely the result of the ruptured balloon material catching on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 8606190
• MDR Text Key: 144951355
• Report Number: 2024168-2019-03783
• 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,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: B1070-040
• Device Lot Number: 80505G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1