MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number B2100-060

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problems Occlusion (1984); Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2017

Event Type  malfunction  

Event Description

Per rn description: armada 35 pta catheter detached within patient.The balloon was inflated then deflated and when doctor was moving the device out it snapped apart leaving half of the balloon inside the patient.The balloon was able to be removed.Per md: the patient did have an occlusion of the innominate vein with small collaterals filling that region.The decision was made to intervene.We upsized the sheath to a 7-french sheath and crossed the lesion with a berenstein catheter as well as a glidewire.After this was crossed, we then used a 6 x 200 mm armada balloon to balloon the entire region.We then used an 8 x 80 armada balloon without good success and we upsized to a 10 x 60 armada balloon.The armada balloon was taken down, and while withdrawing the armada balloon, the proximal portion of the balloon became disrupted and was only partially removed.The remaining distal portion was still on the wire.We then upsized the sheath to a 10-french sheath and used buddy wire technique to snare the rosen wire and removed the entire apparatus.We then placed pressure over the wound, used 4-0 monocryl to close the subcuticular layer over this and we applied venous pressure for greater than 15 minutes.This was then hemostatic.The balloon was evaluated and all the balloon was removed after the snare technique.

• Brand Name: ARMADA
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 6518995
• MDR Text Key: 73617606
• Report Number: 6518995
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: B2100-060
• Device Catalogue Number: B2100-060
• Device Lot Number: 60830G1
• Other Device ID Number: ARAMDA 35 PTA CATHETER 10 MM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 7-FRENCH SHEATH, BERENSTEIN CATHETER, GLIDEWIRE; NO OTHER THERAPIES
• Patient Age: 64 YR
• Patient Weight: 102