MAUDE Adverse Event Report: ABBOTT ABBOTT; ARMADA 35

Catalog Number B1070-060

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Claudication (2550); Pseudoaneurysm (2605)

Event Date 01/05/2016

Event Type  Injury  

Event Description

The armada 35 pta came apart in two separate pieces inside the patient during surgery.The patient presented with peripheral vascular disease with left lower extremity claudication.Left common iliac artery stent, left external iliac artery stent during post inflation the balloon ruptured.At time of post-inflation of the armada 35 pta catheter the balloon ruptured.When attempting to remove the balloon it came out with a separation of the balloon material and the distal portion could not be retrieved through the catheter.Attempted to remove the catheter and just remove it over a wire, but it did not conform to this and could not come through the diseased common femoral artery.Attempts to upside to a larger 7 sheath but that could not be advanced.The patient was bleeding from the groin and developed a pseudoaneurysm.Patient was then put to sleep, and surgeon made an incision to expose the diseased common femoral artery.Placed a vessel loop around this and then created a small arteriotomy in order to retrieve the fragments of the residual balloon that was left in vivo.Once it was removed and examined it was felt to be intact.

• Brand Name: ABBOTT
• Type of Device: ARMADA 35
• Manufacturer (Section D): ABBOTT; abbott park IL
• MDR Report Key: 5416213
• MDR Text Key: 37726402
• Report Number: 5416213
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: B1070-060
• Device Lot Number: 50521G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 73