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

Model Number 45007

Device Problems Entrapment of Device (1212); Mechanical Problem (1384)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Event Description

It was reported that the device bogged down and became stuck on the wire.A 2.4mm jetstream xc catheter was selected for use for a chronic total occlusion (cto) in the distal superficial femoral artery (sfa).During the procedure, the device bogged down and became stuck on a non-bsc wire.The procedure was completed using a covered stent and then completed therapy throughout the tibials and foot and the rest of the procedure went beautifully.No patient complications were reported.

Event Description

It was reported that the device bogged down and became stuck on the wire.A 2.4mm jetstream xc catheter was selected for use for a chronic total occlusion (cto) in the distal superficial femoral artery (sfa).During the procedure, the device bogged down and became stuck on a non-bsc wire.The procedure was completed using a covered stent and then completed therapy throughout the tibials and foot and the rest of the procedure went beautifully.No patient complications were reported.

Manufacturer Narrative

Device returned and evaluated by mfr.Returned product consisted of a jetstream xc-2.4 atherectomy catheter.The guidewire was returned stuck in the device.The device and the catheter shaft were analyzed for damage.The catheter shaft showed no damage.The guidewire was stuck in the device.The guidewire was protruding from the tip approximately 19cm.The guidewire was protruding from the proximal end of the device approximately 157cm.The device was connected to the jetstream console and was functionally tested for rotation issues.The device ran as designed.It was noticed during analysis that the device was run too far distal over the coils on the tip.When the tip is run over the coils, the coils could interfere and get damaged with the rotation and cause the guidewire sticking issue the customer experienced.Dissection of the tip showed the damaged coils inside of the bushing confirming the guidewire sticking issue.Inspection of the remainder of the device, apart from the observed damage, revealed no 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
• MDR Report Key: 9495375
• MDR Text Key: 172004453
• Report Number: 2134265-2019-15962
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024367421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT NAV6 WIRE; ABBOT NAV6 WIRE; ABBOT NAV6 WIRE
• Patient Outcome(s): Required Intervention