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

Model Number	24681
Medical Device Problem Codes	Inflation Problem (1310); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and tactile examination of the returned device identified no kinks or damage along the catheter length.The investigator successfully loaded a boston scientific guidewire through the charger device without any issues or resistance being encountered.No issues were identified that could have contributed to the complaint incident.The customers guidewire was not returned for analysis.An examination of the leur connection threads in the hub identified no issues.The inflation port of the hub manifold was connected to an encore inflation unit with no resistance noted.During the first attempt to inflate the balloon, a pinhole leak was observed in the balloon.No leaks were present between the connection of the encore and the hub port.During the first attempt to inflate the balloon, a pinhole leak was observed in the balloon material.The pinhole was located at the proximal end of the proximal transition zone in the balloon.A microscopic examination of the balloon material could not identify any issues which could potentially have contributed to the pinhole leak.An examination of the markerbands did not identify any damage.No issues were noted with the tip section of the device.
Event or Problem Description
Reportable based on device analysis completed on 28-jan-2019.It was reported that difficulty to load wire and balloon failure to inflate occurred.A 10.0 x40, 75cm charger balloon catheter was selected for use; however, the technician noted that the threads were bad and could not thread something into the catheter.When they finally found a way to get around, the balloon would not come up.No patient complications were reported.However, returned device analysis revealed a pinhole leak.

• 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: 8336656
• Report Number: 2134265-2019-01198
• Device Sequence Number: 16469715
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 09/10/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022633173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1