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

Model Number 45007

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that the infusion line peeled up.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy and angioplasty procedure in the 90% stenosed left superficial femoral artery (sfa) and popliteal artery.There was difficulty advancing the device once in the mid sfa of the left lower extremity.The device was slowly advanced in minimum tip mode until it was unable to advance.At this time, it was observed that the outer layer was peeling up.The device was removed using rex mode.The procedure was successfully completed using a ranger drug-coated balloon in the left sfa and a sterling balloon in the popliteal artery.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The baton and electrical connection were cut off the device from the customer site when received.The device was visually examined for any shaft damage.Visual and microscopic examination showed multiple bends and buckling/kinks along the shaft.The device showed a burst infusion sheath on the catheter shaft located 84cm to 87cm from the tip.The device could not be functionally tested due to the baton and electrical connections being cut off.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device having shaft damage was confirmed.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13933144
• MDR Text Key: 288098693
• Report Number: 2134265-2022-03531
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027355794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White