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

Model Number 24681

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: under 65 years.

Event Description

It was reported that there was a leak, difficulty removing the device, and unretrieved device fragments left in the patient.A 12mm x 60mm x 75cm charger balloon catheter was selected for use in a left upper arm balloon angioplasty and stenting procedure.The left upper subclavian vein had two previously placed stents.One stent appeared to have been placed through the struts of the other.Some fractures were present with exposed nitinol struts.Upon inflation and deflation in the area of the fractured stent, blood was noted in the inflation device, which indicated a pin hole or tear in the balloon material.Resistance was felt upon removal.Some balloon material remained on the stent strut.A second wire was placed next to the first and used to complete the case.A 12mm x 60mm venous wallstent was placed over the second wire and post dilated with a 10mm x 40mm balloon, which opened the in-stent restenosis and trapped any balloon material behind the stent.Angiographic and intravascular ultrasound (ivus) imaging proved to be widely patent.Both the first and second wires were removed without incident.

• 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: 11155458
• MDR Text Key: 226283299
• Report Number: 2134265-2020-18884
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729803874
• UDI-Public: 08714729803874
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026283066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention