MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 24681

Device Problems Deflation Problem (1149); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2020

Event Type  Injury  

Event Description

It was reported that balloon rupture and tip detachment occurred via medwatch # mw5093705. A 12. 0 x60, 75cm charger balloon catheter was advanced for dilation. However, the balloon ruptured even though the rated burst pressure was not reached. Due to the rupture, the balloon was unable to be fully deflated. Upon removal of the device through the sheath, the distal part of the balloon separated and lodged in the vein. It was believed this happened because the unwrapped balloon material caught on the sheath. Follow-up ct scan showed the fragment in the femoral vein.

• Brand Name: CHARGER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9953344
• Report Number: 2134265-2020-04978
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24681
• Device Catalogue Number: 24681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other