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

Model Number	24681
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break, balloon rupture, and detachment occurred.The patient presented with end stage renal disease (esrd) with left upper extremity arteriovenous graft (avg) at risk of thrombosis.The patient underwent interventional radiology (ir) for evaluation and recanalization of stents.A 10.0 x40, 75cm charger balloon catheter was then advanced for dilatation.However, it was noticed that the balloon ruptured and there was fragmentation as well as distraction from catheter mid stent.The physician performed a second criss cross access upstream for snaring and removal of the device.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a charger device was returned for analysis.The device was received with the customers guidewire inserted in the device.For investigation purposes the guidewire was removed from the device.The device was received in two sections due to a shaft break and complete balloon circumferential tear.The recommended introducer/guide sheath size for this device is minimum 7fr.The 11fr sheath used by the customer was returned together with the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete circumferential tear in the balloon material was noted located approximately 45mm distal of the proximal balloon bond.This type of damage is consistent with resistance being encountered excessive tensile force being applied to the device when withdrawing it through the guide/sheath.A visual and examination observed that the tip was damaged.This type of damage is consistent with resistance being encountered and excessive force being applied when attempting to cross the lesion.A visual and tactile examination found the shaft of the device to have completely detached at approximately 5mm distal of the proximal balloon bond.Severe stretching/accordion damage was noted on the distal section of the detached shaft.This type of damage is consistent with resistance being encountered excessive tensile force being applied to the device when withdrawing it through the guide/sheath.A visual examination found the proximal markerband to have completely detached from the device.The markerband most probably became loose due to the severe damage to the shaft.It is not possible to determine when the markerband detached.The detached markerband was not returned for analysis.
Event or Problem Description
It was reported that shaft break, balloon rupture, and detachment occurred.The patient presented with end stage renal disease (esrd) with left upper extremity arteriovenous graft (avg) at risk of thrombosis.The patient underwent interventional radiology (ir) for evaluation and recanalization of stents.A 10.0 x40, 75cm charger balloon catheter was then advanced for dilatation.However, it was noticed that the balloon ruptured and there was fragmentation as well as distraction from catheter mid stent.The physician performed a second criss cross access upstream for snaring and removal of the device.No further 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12665541
• Report Number: 2134265-2021-12736
• Device Sequence Number: 14527577
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 03/18/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026996561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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: 47 YR
• Patient Sex: Female