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

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 8.0 x40, 75cm and another charger balloon catheters were advanced for dilation.However, during inflation, the balloons ruptured.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 8.0 x40, 75cm and another charger balloon catheters were advanced for dilation.However, during inflation, the balloons ruptured.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: a charger device was received for analysis.The device was received with the customers guidewire inserted in the device.The device was received in two sections due to shaft detached at the inner balloon section.The recommended introducer/guide sheath size for this device.A visual examination identified that part of the balloon was detached from the shaft of the device.A complete balloon longitudinal tear was identified located approximately 6mm proximal of the distal balloon sleeve extending to 16 mm distal from the proximal markerband.From the longitudinal tear the balloon had a complete circumferential tear.The proximal section of balloon material had the tip attached.This type of damage most probably occurred when the device was being withdrawn through the sheath prior to a balloon rupture.The rated burst pressure for this device.A visual and examination observed that the tip was attached to the proximal section of the balloon.A visual and tactile examination found the shaft of the device to have completely detached at the balloon section.Severe stretching and accordined damage was noted on the inner shaft of the balloon region.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found the proximal markerband to have completely detached from the device.The detached markerband was not returned for analysis.This concludes the product analysis.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12522770
• Report Number: 2134265-2021-12018
• Device Sequence Number: 4221032
• Product Code: FGE
• UDI-Device Identifier: 08714729804673
• UDI-Public: 08714729804673
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 03/25/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0027038043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1