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

Model Number	24681
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: under 65 years.
Event or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11155458
• Report Number: 2134265-2020-18884
• Device Sequence Number: 2590201
• Product Code: LIT
• UDI-Device Identifier: 08714729803874
• UDI-Public: 08714729803874
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention