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

Model Number 45007

Device Problems Leak/Splash (1354); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

It was reported that the catheter was leaking.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure.A thruway guidewire was also selected.During the procedure, it was difficult advancing the catheter up and over the iliac bifurcation through a non-bsc introducer sheath.The catheter appeared to buckle, and there was a leak from a hole in the side of the device.The procedure was completed with another jetstream xc catheter.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination revealed that there was shaft damage in the form of kinks and buckling located along the shaft 88cm to 98cm from the tip.There was buckling noted 1.5cm from the tip.Visual examination also revealed that the infusion line had burst proximal the kink.The location of the burst infusion line was approximately 98.5cm from the tip.The device showed a leak at the burst infusion line area.The device was set-up and functionally tested per the instructions for use, and the device functioned but at a slow rate due to the catheter shaft damage restricting the drive coil.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that the catheter was leaking.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure.A thruway guidewire was also selected.During the procedure, it was difficult advancing the catheter up and over the iliac bifurcation through a non-bsc introducer sheath.The catheter appeared to buckle, and there was a leak from a hole in the side of the device.The procedure was completed with another jetstream xc catheter.No patient complications were reported.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10224234
• MDR Text Key: 197314243
• Report Number: 2134265-2020-08834
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024788365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL FLEXOR ANSEL GUIDING SHEATH; COOK MEDICAL FLEXOR ANSEL GUIDING SHEATH; COOK MEDICAL FLEXOR ANSEL GUIDING SHEATH