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

Model Number	24681
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and detachment occurred.The target lesion was located in an arteriovenous fistula.An 8.0 x60, 75cm charger balloon catheter was advanced for dilatation.However, during the first inflation, the balloon material burst, detached, and moved to the proximal end of the catheter.While attempting to pull the device though the sheath, the balloon material detached and remained inside the patient.To prevent from further possible migration, a stent was placed over the unretrieved balloon material and the procedure was completed.There were no patient complications and the patient fully recovered.The patient will undergo a fistula revision and the unretrieved balloon material will be removed by then.
Additional Manufacturer Narrative
D4 - lot number: updated from unk to 27865399.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16812465
• Report Number: 2124215-2023-18873
• Device Sequence Number: 5781285
• Product Code: FGE
• UDI-Device Identifier: 08714729804680
• UDI-Public: 08714729804680
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 08/18/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0027865399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown