MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112266-001

Device Problems Entrapment of Device (1212); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece.Visual inspection of the device revealed that the guidewire was not stuck in the device.Visual and tactile analysis noted no irregularities on the shaft of the device.The inner shaft was checked by inserting a jetwire (ln 10559991) in the guidewire lumen.The wire transcended through the full length of the catheter shaft with no restrictions or hesitations.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause has been determined to be use/user error.This root cause is assigned when the device was used contrary to instructions in the dfu.Use of any non-compatible guidewire may compromise performance or damage the jetstream system.(b)(4).

Event Description

It was reported that the catheter became stuck on a non-bsc guidewire.A 2.4mm jetstream® xc atherectomy catheter over a non-bsc guidewire was selected for an atherectomy procedure in the superficial femoral artery (sfa).The device became stuck on the non-bsc guidewire and it would not advance to the location of the lesion.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the catheter would not load onto the guidewire.It was alleged that the metal part on the end of the catheter did not have a hole in it to insert a guidewire.An attempt was made to backload the device over a different.014 guidewire and it tracked all they way but would not push out the tip of the catheter.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5766383
• MDR Text Key: 48716178
• Report Number: 2134265-2016-05846
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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