MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC 14MM X 60MM XXL VASCULAR BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problems Difficult to Remove (1528); Defective Component (2292); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  Injury  

Event Description

The reason for this letter is to report an add'l incident that occurred while performing a venous stent placement.This incident involved a boston scientific xxl vascular large diameter 7 f balloon catheter 14 cm x 6 cm 75 cm.This second incident occurred on 10/04/2019, the first one was on 09/18/2019 which also involved an xxl vascular balloon.The pt was scheduled for venous stent placement to treat may-thurner syndrome on 10/04/2019.The pt was under conscious sedation, and we had completed placement of the venous stent to the left common iliac vein.We used the specified balloon catheter to perform a venoplasty post-stent (venovo 14mm x 100mm) placement.Once the venoplasty was performed post-stent placement and we had completely deflated the balloon, and as we attempted to remove the balloon catheter from the right internal jugular vein, it was noted that the proximal aspect of the balloon detached from the catheter.It was difficult to remove from the internal jugular vein as the balloon folded onto itself and since balloon catheter was retained with the wire at common iliac vein, it was decided to retrieve via the femoral vein.In a sterile fashion, the left femoral vein was accessed in a 10 fr sheath placed in.The guidewire that was already in place from access site of right internal jugular vein to left common iliac vein was moved inferiorly and introduced through the sheath placed at the left femoral vein.A merit medical 6f en snare catheter was advanced using the guidewire to grasp the balloon catheter at the distal end.While maintained at the right internal jugular vein, the balloon catheter was cut at the hub.We used the snare to guide the distal end of the balloon catheter through the femoral vein access.We examined the balloon catheter to ensure complete extraction at venogram was also performed to demonstrate pt's left iliac veins and inferior vena cava.Intravenous ultrasound via the jugular access was used to examine the superior vena cava, inferior vena cava, and the left iliac veins to ensure no foreign bodies and viability of the stent.We believe the balloon catheter was defective.We have notified boston scientific about the incident and about the failure of its balloon catheter.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC 14MM X 60MM XXL VASCULAR BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 9225049
• MDR Text Key: 163933839
• Report Number: MW5090570
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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; Life Threatening
• Patient Age: 80 YR
• Patient Weight: 70