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

Catalog Number B2060-100

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Claudication (2550)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the right mid-superficial femoral artery (sfa) that was moderately tortuous, moderately calcified and 68% stenosed.During the first inflation, the armada 35 6 mm/100 mm ruptured between 14-16 atmospheres.There was difficulty removing the balloon catheter across the aorto-iliac bifurcation into the left iliac, as it was tortuous and calcified and a balloon fragment became stuck on the non-abbott guide wire and could not advance over the guide wire.Force was applied to withdraw the guide wire and balloon into the 6f sheath to attempt to completely encase the fractured balloon inside the sheath.Cut-down was performed in the left groin and the distal balloon marker was removed.A left lower extremity angiogram was performed to mid-sfa to confirm no foreign body occlusion.Post foreign body removal straight shots were performed, excellent doppler flow in foot confirmed post-op.There were no clinically significant delay or adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.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 revealed no other incidents.The investigation determined that the reported difficulties appear to be due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Patient codes: 2550 labeled.Internal file number - (b)(4).The investigation determined that the reported patient effects appear to be due to case circumstances.Photos were received from the customer.The photos show the separated balloon material outside of the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, additional information received on (b)(6) 2019 stated the patient re-presented on an unknown date with claudication symptoms.Angiography was performed and it appeared that the patient had a clot.It was further diagnosed as a piece of the balloon material.A cut down procedure was performed on (b)(6) 2019 and the balloon material was removed.No additional information was provided.

• 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: 8176629
• MDR Text Key: 130764048
• Report Number: 2024168-2018-09835
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: B2060-100
• Device Lot Number: 80212G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: COOK AMPLATZ STIFF
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 78