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

Model Number 112266-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a loss of rotation.A 2.4mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery.The device was successfully primed and worked well through the active procedure.As the went to remove the device in rex mode, there was a pop.It was heard that the motor was running, but the device was not spinning anymore.The device was infusing and aspirating, but the tip was no longer spinning.It was almost like the drive shaft broke.The procedure was completed with this device and the device was removed by a standard pin and pull method with no issues.There were no patient complications and the patient condition was fine.

Manufacturer Narrative

Device evaluated by mfr.:returned product consisted of a jetstream xc-2.4 atherectomy catheter.Visual inspection of the device revealed that the catheter shaft was clear of any defects or deformities.The catheter shaft, pod and the rest of the device was checked for damage.The device was set up.When the forward button was depressed, the device did not function as intended.The motor activated; however, the blades did not spin.The back cover was removed on the pod and it was noticed that the drive pinion gear on the shaft had come loose and was not engaged with the motor gear.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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

It was reported that there was a loss of rotation.A 2.4mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery.The device was successfully primed and worked well through the active procedure.As the went to remove the device in rex mode, there was a pop.It was heard that the motor was running, but the device was not spinning anymore.The device was infusing and aspirating, but the tip was no longer spinning.It was almost like the drive shaft broke.The procedure was completed with this device and the device was removed by a standard pin and pull method with no issues.There were no patient complications and the patient condition was fine.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6356121
• MDR Text Key: 68231708
• Report Number: 2134265-2017-01448
• 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: 02/07/2017

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: 04/04/2017
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 187814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR