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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that the device became entrapped on the guidewire.A 2.1mm jetstream xc atherectomy catheter was selected for a left leg angiogram to treat claudication.During the second pass, however, the device blades stopped spinning.The pump was still running and it sounded like the motor was trying to work, but nothing happened.No error message was observed.The physician attempted to restart the device, but it was entrapped on the wire and would not budge.The entire system, wire and catheter, had to be removed.They were able to be separated once removed from the body.A different device was used to complete the procedure, and there were no complications reported.

Manufacturer Narrative

Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a jetstream xc-2.1 atherectomy device.The device and the catheter shaft were analyzed for damage.The returned device showed buckling/kinks located 1cm and 4cm from the tip.The device was connected to the jetstream console per the instructions for use (ifu) and was functionally tested for any issues or errors.A test.014 thruway guidewire was inserted into the tip of the catheter and the wire transcended through the device with no hesitations or restrictions.The device primed as designed.The guidewire was inserted into the gard.The device did not function as designed.The motor was heard; however, no tip rotation was noticed.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the blades would stop.The gear was slid back on the shaft and the device was run again.The gear again slid off the shaft.Inspection of the remainder of the device, apart from the observed damage showed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The complaint for blades not spinning was confirmed as well as shaft damage.The guidewire sticking was not confirmed.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17321637
• MDR Text Key: 319234355
• Report Number: 2124215-2023-36310
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• 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: 0030858753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1