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	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The mildly stenosed target lesion was located in the mildly tortuous and mildly calcified iliac vein.A 10.0 x80, 75cm charger balloon catheter was advanced and used to dilate the lesion; however, during the initial inflation at less working pressure for few seconds, the balloon ruptured.Another 12.0 x80, 75cm charger balloon catheter was advanced and used to dilate the lesion; however, during the initial inflation at less working pressure for few seconds, the balloon also ruptured.Both devices were simply pulled out from the patient and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The mildly stenosed target lesion was located in the mildly tortuous and mildly calcified iliac vein.A 10.0 x80, 75cm charger balloon catheter was advanced and used to dilate the lesion; however, during the initial inflation at less working pressure for few seconds, the balloon ruptured.Another 12.0 x80, 75cm charger balloon catheter was advanced and used to dilate the lesion; however, during the initial inflation at less working pressure for few seconds, the balloon also ruptured.Both devices were simply pulled out from the patient and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: a charger 10mm x 80mm, 14atm, 75cm, batch 26306075 was returned for analysis.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 16mm in length and extended from a position 26mm proximal of the distal markerband to 8mm distal of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic 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.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: 12105154
• Report Number: 2134265-2021-08472
• Device Sequence Number: 11907405
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: 08714729803812
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 11/05/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026306075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR