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

Model Number 112266-001

Device Problems Difficult to Remove (1528); Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination showed the shaft was completely separated 50cm from the tip.It was noticed that the separated part of the catheter shaft was buckled and kinked 4cm from the tip to 24cm proximally.Damage was noticed on the infusion sheath/line.Functional testing was not completed due to the extreme damage to the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the device separated, there was difficulty removing the device from the lesion, the blades were not spinning as intended, and surgery was needed due to this issue.A 2.4mm jetstream® xc atherectomy catheter was selected for use during an atherectomy procedure in the patient's severely calcified right superficial femoral artery (sfa).The patient's condition prior to the procedure was poor right leg circulation.A 7f non-bsc sheath was inserted into the left groin, and was then guided up and over the aortic bifurcation.The jetstream was then inserted and used to eliminate the target calcium.Then the physician started to rex the device out to complete the procedure.The device rexed out as intended up until the bifurcation by the iliac artery where the tip of the sheath was located.All of the sudden, the device stopped moving.The physician advanced the device forward, and the device was still working a little bit, but then it stopped completely.They then cut the jetstream device (on the portion of the device outside of the patient) to try and pull it out together with the sheath, as it was only 2-3 mm past the tip of the sheath.However, because it was realized that the device was stuck on calcium, the physician decided against continuing to pull.The procedure was stopped and the physician decided to perform open surgery and cut down to the location of the stuck device in order to safely remove the devices.Once the sheath and jetstream were completely out of the body, it was noted that the jetstream catheter was partially separated-appearing to be hanging by a thread.The metal part was separated from the black part.The time of device separation is unknown, however the physician realized it was separated upon attempting to withdraw and rex the device out of the patient and into the sheath.The jetstream device was completely removed from the patient; no portion of the device was left inside of the patient.After the procedure to remove the jetstream from the patient, the physician tried to place a 5x150 innova stent in hopes to avoid doing a bypass, but due to the severe calcification of the lesion the device could not cross.Therefore the physician performed a femoral endarterectomy and successfully regained blood flow to the patient¿s leg.This was done by cutting the artery in half and patching it with a bovine pericardial patch/bypass.The operating room time for the femoral endarterectomy procedure was already scheduled for this patient, just in case the jetstream procedure did not successfully clear out the calcium with the jetsteam, so the physician was prepared for the procedure.The patient¿s condition after the procedure was stable and unharmed.Blood flow was successfully regained in the right leg and the surgical lesion was stable.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7542043
• MDR Text Key: 109222358
• Report Number: 2134265-2018-04541
• 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
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2019
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 0020772882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR