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	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the not heavily calcified and non-tortous left common iliac artery.A 10.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during inflation at approximately 8 atmospheres, the balloon ruptured.Another 10.0 x40, 75cm charger balloon catheter was advanced; however, during inflation at 8 atmospheres, the balloon also ruptured.Both devices were removed safely from the patient's body and it was noted that both balloons had visible pinholes.The procedure was completed with another of same device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the not heavily calcified and non-tortuous left common iliac artery.A 10.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during inflation at approximately 8 atmospheres, the balloon ruptured.Another 10.0 x40, 75cm charger balloon catheter was advanced; however, during inflation at 8 atmospheres, the balloon also ruptured.Both devices were removed safely from the patient's body and it was noted that both balloons had visible pinholes.The procedure was completed with another of same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: charger was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 4mm proximal from the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during 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: 11409042
• Report Number: 2134265-2021-02723
• Device Sequence Number: 4053319
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 11/02/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026283031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR