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 Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 65 years old.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in two different vessel located in the superficial femoral artery (sfa) and tibial peroneal trunk.A 4.0mm x 40mm x 135cm charger balloon catheter was advanced in the sfa, but the balloon ruptured.The device was replaced with a 3mm x 40mm x 145cm coyote es balloon catheter and it worked okay.Then they worked on a lower vessel that was measured via intravascular ultrasound.A 3mm x 40mm x 145cm and 2mm x 40mm x 144cm coyote es balloon catheters were advanced in the tibial peroneal trunk but also ruptured.The balloon catheters were removed and they tried inflating them outside the patient's body.It was noted that there was an incision that it looks like it was poked through.The procedure was completed with a half size up or half size down from the third balloon catheter.No patient complications were reported and the patient's status was 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: 8226577
• Report Number: 2134265-2018-64630
• Device Sequence Number: 19350180
• Product Code: LIT
• UDI-Device Identifier: 08714729804109
• UDI-Public: 08714729804109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2019

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: 10/31/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022877843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1