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

Model Number 030557-020

Device Problems Failure to Prime (1492); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Examination of the returned complaint device revealed that the outer infusion sheath on the catheter shaft had burst and was leaking fluid.The inner sheath on the catheter shaft has been stretched and compressed onto the spiral cut aspiration lumen causing the sheath to interfere with the drive coil rotation.Functional analysis was done by completing the set up procedure and was noticed that the priming sequence was not functioning properly due to the outer infusion sheath being ruptured.They removed the outer plastic shell on the pod and disconnected the drive coil shaft from the motor.After disconnecting, the forward and reverse buttons on the mouse control were pushed and the motor did run in both directions forward and reverse.Dissection of the catheter shaft showed that the inside of the exhaust lumen was completely occluded with a heavy clot burden.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 29jul2015.It was reported that during preparation, the device failed to prime.This 1.85mm jetstream atherectomy catheter was selected; however, the device would not prime and there was no motion from the distal tip of the catheter.The device was not used.The procedure was completed with a different device.No patient complications were reported and the patient's status is fine.However, device analysis revealed that the outer sheath burst.

• Brand Name: JETSTREAM® 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: 5032029
• MDR Text Key: 24124304
• Report Number: 2134265-2015-05729
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/29/2015

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: 04/03/2015
• Device Model Number: 030557-020
• Device Lot Number: 130403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1