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

Model Number	24681
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter got stuck on the guidewire.Treatment was being performed in the superficial femoral artery (sfa).It was a long case, which the physician was using a zipwire.The zipwire had been in the patient for a long time (greater than 20 minutes).When the physician advanced a 6.0 x20 charger balloon over the zipwire it got stuck.Both the charger and zipwire were removed from the patient together.Once outside of the patient, saline was applied and the two separated.The zipwire was then advanced again into the patient.The wire wetted between each device advancement.Another balloon catheter was advanced and worked fine.The procedure was completed with an innova stent with no complications to the patient.The patient was noted to be fine.

• 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: 7937890
• Report Number: 2134265-2018-61602
• Device Sequence Number: 14020629
• Product Code: FGE
• UDI-Device Identifier: 08714729804345
• UDI-Public: 08714729804345
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 05/09/2019
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0019234134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1