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

Model Number	24681
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon burst.An 8mm x 80mm charger balloon was selected for use in an intervention in the iliac.The target lesion was moderately to severely calcified.During pre-dilatation, the balloon burst at 10atm on the second inflation.Open surgery was required.The balloon was successfully removed.No device fragments remained inside the patient.The procedure was not completed.The patient was in good condition following surgery and was discharged.The patient fully recovered.
Event or Problem Description
It was reported that the balloon burst.An 8mm x 80mm charger balloon was selected for use in an intervention in the iliac.The target lesion was moderately to severely calcified.During pre-dilatation, the balloon burst at 10atm on the second inflation.Open surgery was required.The balloon was successfully removed.No device fragments remained inside the patient.The procedure was not completed.The patient was in good condition following surgery and was discharged.The patient fully recovered.It was further reported that the balloon could not be retracted through the sheath.Therefore, surgery was needed to remove the balloon.
Additional Manufacturer Narrative
Device eval by manufacturer: the charger balloon was returned inside a 7fr sheath, which meets the sheath compatibility specification.A visual examination identified that the balloon was not folded, which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 5mm distal of the proximal balloon sleeve.The distal section of balloon material was found to be bunched towards the tip of the device.For investigation purposes, the investigator straightened the distal section of balloon material and found it to be torn longitudinally beginning at the circumferential tear and extending for approximately 30mm distally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely stretched/damaged and kinked at more than one location between the proximal and distal balloon sleeves.This type of damage is consistent with excessive tensile force being applied to the device.A microscopic examination found both markerbands to be severely damaged.The proximal markerband was also noted to have moved distally most likely due to the damage to the shaft of the device.No other issues were identified during 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: 12215448
• Report Number: 2134265-2021-09435
• Device Sequence Number: 4301496
• Product Code: LIT
• UDI-Device Identifier: 08714729804703
• UDI-Public: 08714729804703
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 02/23/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026856325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention