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

Model Number	24682
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear occurred.Vascular access site was obtained via anterior tibial (at) artery.The 100% stenosed, 130mmx5mm, target lesion was located in the mildly tortuous and moderately calcified distal superficial femoral artery or proximal popliteal artery.After a 6f guide catheter was inserted and a laser atherectomy was utilized over a.014 wire, a 6.0 x150, 135cm charger balloon catheter was advanced for dilation.The balloon was inflated at nominal pressure for 1 minute.However, upon removal, the balloon wing was difficult to pass through from the hemostatic aspect of the sheath.Additionally, force was cautiously applied to coax the balloon out of the sheath causing the balloon to tear as it was removed out of the patient's body.The balloon was removed intact, and no detached fragments noticed inside the patient.Furthermore, after contrast injection and visualization of the target lesion, additional angioplasty was performed using a 5x150x150 sterling balloon catheter.The sterling balloon was removed, and procedure was completed successfully without any further complications.No patient complications were reported.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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: 16747018
• Report Number: 2124215-2023-14446
• Device Sequence Number: 8626797
• Product Code: LIT
• UDI-Device Identifier: 08714729804321
• UDI-Public: 08714729804321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2025
• Device Model Number: 24682
• Device Catalogue Number: 24682
• Device Lot Number: 0030391759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Female