MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) JETSTREAM® PV ATHERECTOMY SYSTEM CONSOLE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 050599-001R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the jetstream console was intermittently not pulling saline through.A jetstream® pv atherectomy system console was selected for an atherectomy procedure.During the procedure, the unit was intermittently not pulling saline through.The procedure was completed with this device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the console was received without physical damage.The jetstream console was tested.During testing, the jetstream console functioned properly.No failure was observed when power on, no failure was observed when connecting to catheter, no failure was observed before and after prime.The system did not show any issue.The console passed all functional test requirements.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the jetstream console was intermittently not pulling saline through.A jetstream pv atherectomy system console was selected for an atherectomy procedure.During the procedure, the unit was intermittently not pulling saline through.The procedure was completed with this device.There were no patient complications reported.

• Brand Name: JETSTREAM® PV ATHERECTOMY SYSTEM CONSOLE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7643043
• MDR Text Key: 112555919
• Report Number: 2134265-2018-05996
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082664
• 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,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 050599-001R
• Device Catalogue Number: 050599-001R
• Device Lot Number: JET0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1