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

Model Number	24683
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue and removal difficulties occurred.The 50% stenosed target lesion, greater than 200mmx6mm was located in the diffused mildly tortuous and moderately calcified vessel.After laser atherectomy was performed, a 6.0 x200, 135cm charger balloon catheter was advanced for dilatation.However, the doctor noticed a slower than normal balloon deflation time during initial inflation at 8 atmospheres for 30 seconds.The balloon was removed using a surgical standard pin and pull technique.Upon inspection, it was noticed that the balloon shaft was elongated, stretched and kinked in the mid portion.A 6x200 sterling balloon catheter was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
It was reported that this device was used during a pulmonary vein isolation (pvi) procedure which is a procedure to treat an irregular heart rhythm.As per the instructions for use (ifu), the charger pta balloon catheter is not for use in the coronary arteries.

• 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: 17715926
• Report Number: 2124215-2023-46014
• Device Sequence Number: 2189578
• Product Code: LIT
• UDI-Device Identifier: 08714729804369
• UDI-Public: 08714729804369
• 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): 09/08/2023

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: 11/14/2025
• Device Model Number: 24683
• Device Catalogue Number: 24683
• Device Lot Number: 0030542329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Race: White