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

Model Number 10706

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2019

Event Type  malfunction  

Event Description

It was reported that a catheter break occurred.An angiojet spiroflex catheter was selected for treatment.However, during preparation, the piece of the device where saline goes through became cracked.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the spiroflex thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Inspection of the device presented no damage or irregularities.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range without any leaks from the device or console errors/alarms.

Event Description

It was reported that a catheter break occurred.An angiojet spiroflex catheter was selected for treatment.However, during preparation, the piece of the device where saline goes through became cracked.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ANGIOJET SPIROFLEX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8910935
• MDR Text Key: 154889840
• Report Number: 2134265-2019-09967
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (y/n): N
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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: 02/23/2021
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0023674447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1