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

Model Number	24681
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a visual and tactile examination of the returned device identified no kinks or damage along the entire length of the device.An examination of the balloon identified that the balloon had been inflated and was refolded.The device was attached to an encore inflation unit and during the first attempt to inflate the balloon a pinhole leak was identified at the proximal edge of the proximal transition zone in the balloon material.No other leaks were present.An examination of the markerbands identified no damage.
Event or Problem Description
Reportable based on device analysis completed on  31-jan-2019.It was reported that balloon leak occured.The target lesion was located in the brachial.A 10.0 x40, 75cm charger balloon catheter was advanced for dilation.However, it was noted that the balloon could not fully inflate due to leak.The procedure was completed with a different device.There were no patient complications nor injuries were reported.However, returned device analysis revealed 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: 8356471
• Report Number: 2134265-2019-01514
• Device Sequence Number: 11313452
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: 10/22/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022831018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1