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

Model Number 45007

Device Problems Break (1069); Noise, Audible (3273); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

It was reported that the internal drive shaft broke.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the right superficial femoral artery.The device was used over a 0.014" thruway guidewire, 300cm.During the procedure, the device stopped working abruptly after approximately 10 seconds of use.A notable difference in sound was heard that sounded like the device's internal shaft broke.No error message was observed.The procedure was completed with another 2.4mm jetstream xc catheter.No patient complications were reported, and the patient did well post-procedure.

Manufacturer Narrative

Device analysis by mfr: the device was visually and microscopically inspected for damage.The catheter shaft showed kinking and buckling 1.5cm from the tip.Functional analysis was completed by setting the device up in the jetstream console.When the connector of the jetstream catheter was connected to the console an error code appeared on the console stating a pod error.The connector on the device was inspected for any bent or loose pins, no damage was noticed.The pod was opened to inspect for any internal damage or loose wiring, no damage or issues were noticed.A pcba board was installed and the device was reconnected to the console.The device communicated as designed and no errors were present.The device ran for a period of 3 minutes with no issues or errors.The failed pcba board was reinstalled and the device was connected to the power supply and current was delivered to the card.The device was then checked and noted to be below specification.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 internal drive shaft broke.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the right superficial femoral artery.The device was used over a 0.014" thruway guidewire, 300cm.During the procedure, the device stopped working abruptly after approximately 10 seconds of use.A notable difference in sound was heard that sounded like the device's internal shaft broke.No error message was observed.The procedure was completed with another 2.4mm jetstream xc catheter.No patient complications were reported, and the patient did well post-procedure.

• 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: 10265436
• MDR Text Key: 198576966
• Report Number: 2134265-2020-09206
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024570152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR