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

Model Number	24683
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.The less than 50% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery (sfa).A 6.0 x200, 135cm charger balloon was advanced over a non-boston scientific (bsc) guidewire and was inflated twice without any issue.However, upon removal, a small dissection in the distal portion of the sfa was noticed.The balloon was reinserted with difficulty into a 6fr x 45cm non-bsc sheath and was advanced into the lesion and was reinflated over the dissected area.The balloon was removed after deflating; however, the dissection remained.A 7mm x 40mm innova stent was placed into the lesion, and the same balloon was reinserted for post-dilation.Negative pressure was applied on the balloon, but it would not track on guidewire.The device was removed intact, and a 6mm x 40mm x 135cm charger balloon was used to post-dilate the stent.The procedure was completed without further issue.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19951676
• Report Number: 2124215-2024-48751
• Device Sequence Number: 15655987
• Product Code: LIT
• UDI-Device Identifier: 08714729804369
• UDI-Public: 08714729804369
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/09/2024

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: 02/14/2026
• Device Model Number: 24683
• Device Catalogue Number: 24683
• Device Lot Number: 0031046730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 02/15/2023
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Race: White