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

Model Number 45007

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/01/2019

Event Type  Injury  

Event Description

It was reported that a jetstream device became stuck on a wire and fractured the wire.A 2.4mm jetstream athrectomy catheter and a.014 thruway guidewire were selected for a procedure in the superficial femoral artery (sfa).During the procedure, the jetstream catheter was in blades down mode and became stuck on the wire.A piece of the guidewire became twisted and fractured inside the patient's leg.The fractured portion of the wire was retrieved using a snare.Everything else was removed by simply pulling out.There were no patient complications.The procedure was completed with a different device.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The guidewire was not in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed no damage to the shaft.A.014 guidewire was inserted into the device and transcended through the device with no hesitation or restrictions.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that a jetstream device became stuck on a wire and fractured the wire.A 2.4mm jetstream athrectomy catheter and a.014 thruway guidewire were selected for a procedure in the superficial femoral artery (sfa).During the procedure, the jetstream catheter was in blades down mode and became stuck on the wire.A piece of the guidewire became twisted and fractured inside the patient's leg.The fractured portion of the wire was retrieved using a snare.Everything else was removed by simply pulling out.There were no patient complications.The procedure was completed with a different device.

• 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: 8930587
• MDR Text Key: 155507378
• Report Number: 2134265-2019-10217
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023659924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .014 THRUWAY GUIDEWIRE; .014 THRUWAY GUIDEWIRE; .014 THRUWAY GUIDEWIRE
• Patient Outcome(s): Required Intervention