MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45006

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2018

Event Type  malfunction  

Event Description

It was reported that the device stalled.A 1.6mm jetstream catheter was being used during an anterior tibial atherectomy treatment procedure but kept stalling.The catheter was exchanged and the case was completed successfully.There were no patient complications.The patient was reported to be stable post procedure.

Event Description

It was reported that the device stalled.A 1.6mm jetstream catheter was being used during an anterior tibial atherectomy treatment procedure but kept stalling.The catheter was exchanged and the case was completed successfully.There were no patient complications.The patient was reported to be stable post procedure.It was further reported the catheter stalled while atherectomy was taking place.The device stalled once, stopping all activity completely with no error messages and would not start again.Returned product consisted of a jetstream sc-1.6 atherectomy catheter.No damage was noticed on the device.The device was set up per the dfu and functioned as designed with no issues.The device was run for a period of 3 consecutive minutes with no stalling or errors.

Event Description

It was reported that the device stalled.A 1.6mm jetstream catheter was being used during an anterior tibial atherectomy treatment procedure but kept stalling.The catheter was exchanged and the case was completed successfully.There were no patient complications.The patient was reported to be stable post procedure.It was further reported the catheter stalled while atherectomy was taking place.The device stalled once, stopping all activity completely with no error messages and would not start again.

• Brand Name: JETSTREAM SC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7797751
• MDR Text Key: 117608636
• Report Number: 2134265-2018-60181
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2019
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0021506885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR