MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a charger 10 x 60,75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure and a pinhole leak was identified 9mm proximal from the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the markerbands that could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21-jan-2021.It was reported that inflation failure were encountered.The target lesion was located in the right iliac artery and superficial femoral artery.The lesion was 90% stenosed with mild calcification.A 10.0 x 60, 75cm charger balloon catheter was advanced for dilatation.However, the balloon would not hold its pressure and was not ruptured.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a balloon pinhole.

• 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: 11251649
• Report Number: 2134265-2021-00977
• Device Sequence Number: 14252629
• Product Code: FGE
• UDI-Device Identifier: 08714729803805
• UDI-Public: 08714729803805
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 10/09/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026157099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR