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

Model Number 24681

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: used (b)(6) 2019 as the correct date was not provided.

Event Description

It was reported that balloon rupture occurred.The 80% target lesion was located in the very tortuous and calcified right superficial femoral artery.A 4.0 x80, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device.

• Brand Name: CHARGER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8570924
• MDR Text Key: 143812208
• Report Number: 2134265-2019-04728
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729804130
• UDI-Public: 08714729804130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022423057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1