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

Model Number	24681
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 5.0 x40, 135cm charger balloon catheter was advanced for dilatation.After inflation, the device was attempted to be removed over the guide wire.However, the wire was locked onto the device.Both the balloon and wire were removed together as a unit.Furthermore, a kink near the hub was noted.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: charger 5.0 x40, 135cm was received for analysis.The device was received loaded on to the customers guidewire.A the catheter is compatible with a 0.035in (0.89 mm) guidewire.The investigator confirmed that the size of guidewire advanced through the charger device was 0.035.The investigator was unable to remove the guidewire from the device due to severe stretching damage to the shaft.A visual examination identified that the balloon was not folded and had been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination identified severe stretching damage to the shaft of the device beginning at the strain relief and extending approximately 50mm distally.This type of damage is consistent with excessive tensile force being applied to the device.Kinking reported at the same location could not be confirmed due to the stretching damage.This concludes the product analysis.
Event or Problem Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 5.0 x40, 135cm charger balloon catheter was advanced for dilatation.After inflation, the device was attempted to remove over the guide wire.However, the wire was locked onto the device.Both the balloon and wire were removed together as a unit.Furthermore, a kink near the hub was noted.The procedure was completed with no patient complications 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14052972
• Report Number: 2134265-2022-03466
• Device Sequence Number: 17361254
• Product Code: LIT
• UDI-Device Identifier: 08714729804246
• UDI-Public: 08714729804246
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 11/04/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026298241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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 Sex: Unknown