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	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x80, 135cm charger balloon catheter was prepped and advanced for dilatation.However, during inflation, contrast was seeping out and a hole was noted in the balloon.The device was removed, and a new charger balloon was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that a hole in the balloon occurred a 5.0 x80, 135cm charger balloon catheter was advanced for dilation.The device was prepped and inserted, however, when the balloon was inflated contrast was seeping out, and a hole in the balloon was noted.The device was removed.A new charger balloon was used to complete the procedure without complication.There were no patient complications reported.It was further reported that the complaint device was a 6.0x80, 135 cm charger balloon catheter and not 5.0 x80, 135cm charger balloon catheter as previously reported.
Event or Problem Description
It was reported that a hole in the balloon occurred.A 5.0 x80, 135cm charger balloon catheter was advanced for dilation.The device was prepped and inserted, however, when the balloon was inflated contrast was seeping out, and a hole in the balloon was noted.The device was removed.A new charger balloon was used to complete the procedure without complication.There were no patient complications reported.It was further reported that the complaint device was a 6.0x80, 135 cm charger balloon catheter and not 5.0 x80, 135cm charger balloon catheter as previously reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a charger device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.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 28mm distal from the distal markerband.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15633722
• Report Number: 2124215-2022-42206
• Device Sequence Number: 12249344
• Product Code: FGE
• UDI-Device Identifier: 08714729804413
• UDI-Public: 08714729804413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022

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: 03/06/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0025319887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 11/29/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2020
• 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