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	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with artificial blood vessel occlusion in the left upper extremity.The target lesion was located in the left anterior descending artery.A 7.0 x40, 75cm charger balloon catheter was advanced for pre-dilatation.However, on the second inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with artificial blood vessel occlusion in the left upper extremity.The target lesion was located in the left anterior descending artery.A 7.0 x40, 75cm charger balloon catheter was advanced for pre-dilatation.However, on the second inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion has normal stenosis and was moderately calcified.The balloon was inflated twice at 16 and 18 atmospheres (atm) respectively for a few seconds, however, on the second inflation at 18 atm, the balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with artificial blood vessel occlusion in the left upper extremity.The target lesion was located in the left anterior descending artery.A 7.0 x40, 75cm charger balloon catheter was advanced for pre-dilatation.However, on the second inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion has normal stenosis and was moderately calcified.The balloon was inflated twice at 16 and 18 atmospheres (atm) respectively for a few seconds, however, on the second inflation at 18 atm, the balloon ruptured.
Additional Manufacturer Narrative
Updated b5: describe event or problem.Device evaluated by mfr: a charger device was received for analysis, the following attributes were examined.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 28mm in length and extended from a position 8mm distal of the proximal markerband to 1mm distal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.This concludes 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
• 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: 15668091
• Report Number: 2124215-2022-43134
• Device Sequence Number: 6444068
• 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): 12/06/2022

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: 12/06/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0028509537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 11/25/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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 Age: 60 YR
• Patient Sex: Male