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

Model Number	24681
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 70-80% stenosed target lesion was located in the non-tortuous and non-calcified iliac artery.A 10.0 x 40, 75cm charger balloon catheter was advance for dilatation.Upon removal, the balloon was deflated and was unable to track over wire.The balloon was removed intact together with the wire.The procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that device entrapment occurred.The 70-80% stenosed target lesion was located in the non-tortuous and non-calcified iliac artery.A 10.0 x 40, 75cm charger balloon catheter was advance for dilatation.Upon removal, the balloon was deflated and was unable to track over wire.The balloon was removed intact together with the wire.The procedure was completed successfully.No patient complications were reported.It was further reported that the guidewire used was a non-boston scientific guidewire.It is still in the charger balloon.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and underwent a visual and tactile examination.A shaft kink 155mm distal from the distal end of the strain relief was noted.No issues were identified with the balloon material, the markerbands, and the tip of the device.

• 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: 20052298
• Report Number: 2124215-2024-51312
• Device Sequence Number: 12773516
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/19/2024

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: 04/17/2026
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0031445043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK BENTSON GUIDEWIRE; COOK BENTSON GUIDEWIRE
• Patient Sex: Unknown