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

Model Number B1100-040

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601)

Patient Problem Stenosis (2263)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

A venogram of the bilateral upper extremities to assess for stenosis.The left brachial vein was accessed under ultrasound guidance.The venogram demonstrated multiple stenosis in the left subclavian vein.Balloon angioplasty was performed with 6mm, 8mm, and 10mm balloons.After 2 inflations with the 10mm balloon, the balloon ruptured, and contrast was noted in the subclavian vein.Under fluoroscopic guidance, the balloon catheter was pulled back into the sheath and resistance was noted.Under steady pressure the catheter was withdrawn from the sheath, but resistance was again noted when the balloon catheter was out of the sheath.At this point, the sheath and balloon were withdrawn from the left brachial vein and skin.Additional resistance was noted.Assessment at this point was that the balloon catheter was stretched and sheared with near separation of the balloon portion of the catheter with a portion external to the left arm and a portion that was likely intravascular in the left brachial vein.The proximal portion of the balloon catheter and sheath were removed over a wire.At this point, consult with vascular surgery was obtained.A small cut-down to the left brachial vein to extract the foreign body was performed.

• Brand Name: ARMADA
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 13884978
• MDR Text Key: 287797386
• Report Number: 13884978
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2022,03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1100-040
• Device Catalogue Number: B1100-040
• Device Lot Number: 10903G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9490 DA
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White