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

Model Number 45007

Device Problems Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: elderly.

Event Description

It was reported that the infusion or aspiration line busted.A 2.4mm jetstream xc catheter was selected for a lower extremity atherectomy procedure, in a long and very tight superficial femoral artery (sfa).From the start of the procedure, there was difficulty advancing the catheter through the lesion.After 10 to 15 minutes of attempting to advance the catheter, the device was removed.The proximal portion of the catheter outside the sheath had accordioned and the distal end of the catheter had pulled away from the main part of the catheter.It was noted that the infusion or aspiration line busted.The procedure was completed using another jetstream device with good results.No patient complications were reported.

Event Description

It was reported that the infusion or aspiration line busted.A 2.4mm jetstream xc cathether was selected for a lower extremity atherectomy procedure, in a long and very tight superficial femoral artery (sfa).From the start of the procedure, there was difficulty advancing the catheter through the lesion.After 10 to 15 minutes of attempting to advance the catheter, the device was removed.The proximal portion of the catheter outside the sheath had accordioned and the distal end of the catheter had pulled away from the main part of the catheter.It was noted that the infusion or aspiration line busted.The procedure was completed using another jetstream device with good results.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: device was returned for analysis and evaluated by manufacturer.It was observed that there was shaft damage in the form of kinks located 1cm and 5cm.It was also observed that the infusion line had burst damage proximal to the buckling/kinks, damage to infusion line was approximately 7.5cm to 13.5cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Age at time of event - elderly.

• 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: 9383274
• MDR Text Key: 174381668
• Report Number: 2134265-2019-14517
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024249329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM; EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM