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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent endovascular angioplasty of upper limb veins.A 7.0 x40, 75cm charger balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another 7x40 boston scientific pta balloon catheter.No patient complications nor injuries were reported.The patient was stable after procedure.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older e1: initial reporter facility name: (b)(6).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 8mm proximal from the proximal 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.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent endovascular angioplasty of upper limb veins.A 7.0 x40, 75cm charger balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another 7x40 boston scientific pta balloon catheter.No patient complications nor injuries were reported.The patient was stable after procedure.It was further reported that the 40% stenosed target lesion was located in a mildly tortuous and mildly calcified artificial blood vessel at basilic vein.The balloon ruptured during the first inflation for 20 seconds.And the device was removed along with the guidewire.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent endovascular angioplasty of upper limb veins.A 7.0 x40, 75cm charger balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another 7x40 boston scientific pta balloon catheter.No patient complications nor injuries were reported.The patient was stable after procedure.It was further reported that the 40% stenosed target lesion was located in a mildly tortuous and mildly calcified artificial blood vessel at basilic vein.The balloon ruptured during the first inflation for 30 seconds.And the device was removed along with the guidewire.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.E1: initial reporter facility name: (b)(6).

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15803766
• Report Number: 2124215-2022-46847
• Device Sequence Number: 17548499
• Product Code: FGE
• UDI-Device Identifier: 08714729804536
• UDI-Public: 08714729804536
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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: 08/31/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0027942918
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 12/02/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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
• Patient Sex: Unknown