MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

It was reported that the device partially separated.A 2.4mm jetstream xc catheter was selected for use for a patient procedure in the common femoral artery.The physician made one pass in blades down and then noticed some resistance advancing the catheter.The catheter was then removed and it was then noticed that, distal to the blades, the catheter seemed to have snapped in half without completely breaking apart.The physician decided that the anatomy of the iliac may have contributed to the device issues and decided not to continue any treatment.The patient will be referred to another physician for a surgical procedure due to anatomical challenge.No patient complications were reported.Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination showed that the devices power and baton were severed from the device.It was notice that there were multiple areas of small kinks on the catheter shaft from the tip to 11cm proximal.There was damage on the shaft damage (aspiration sheath buckled) at 1.3cm from the tip.Visual examination noticed that the infusion line had burst proximal the kinks and damage.The location of the burst infusion line was approximately 13.5 to 15cm from the tip.The damage that was noticed is consistent with sheath interference during the procedure.Pushing, pulling and torquing of the device could possibly cause the damage that was noticed.The buckling/kinks on the shaft causes the fluid to back up inside of the infusion sheath and causes the infusion sheath to burst proximal of the buckling.The device could not be set-up and functionally tested due to the baton and the power cords being severed from the device.There was no drive shaft break noticed on the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7974827
• MDR Text Key: 124549953
• Report Number: 2134265-2018-62005
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022107274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1