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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with iliac vein compression stenosis.The more than 80% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A 35 guidewire was passed, and angiography showed stenosis after expansion of balloon with diameter of 8, 10 and 12.A 12.0 x80, 75cm charger balloon catheter was advanced for dilatation for stent implantation.However, during second inflation at 6-7 atmospheres for several seconds, the balloon ruptured.The device was removed in a normal way and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded and had been subjected to positive pressure.Blood was noted inside the balloon which is indicative of a device leak.A leak test found a balloon pinhole located approximately 18mm distal of the proximal markerband.No other issues were noted with the balloon material.The rated burst pressure for this device is 12 atmospheres as per specification.A visual and tactile examination identified no issues with the shaft of the device.A visual examination found no issues with the markerbands or tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with iliac vein compression stenosis.The more than 80% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A 35 guidewire was passed, and angiography showed stenosis after expansion of balloon with diameter of 8, 10 and 12.A 12.0 x80, 75cm charger balloon catheter was advanced for dilatation for stent implantation.However, during second inflation at 6-7 atmospheres for several seconds, the balloon ruptured.The device was removed in a normal way and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18957957
• Report Number: 2124215-2024-16852
• Device Sequence Number: 21155039
• Product Code: FGE
• UDI-Device Identifier: 08714729803881
• UDI-Public: 08714729803881
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 08/29/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0030050531
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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 Age: 48 YR
• Patient Sex: Male