MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY

Model Number 10707

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported that shaft break occurred via medwatch mw5105369 attached.An angiojet spiroflex was used for an emergent left heart catheterization.Upon loading the catheter onto the wire, prior to insertion into the body, the catheter broke and fluid was leaking around the catheter shaft.The catheter was immediately removed and procedure was completed with a different device.No patient complications were reported.

• Brand Name: ANGIOJET SPIROFLEX VG
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13282620
• MDR Text Key: 284019167
• Report Number: 2134265-2021-16756
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889441
• UDI-Public: 08714729889441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

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: 08/01/2023
• Device Model Number: 10707
• Device Catalogue Number: 10707
• Device Lot Number: 0028041349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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