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

Model Number 45007

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that the jetstream device was difficult to remove from the patient, and there was an issue with the coating integrity.A jetstream xc was selected for use in the atherectomy procedure to treat the patient condition of peripheral artery disease (pad).The target lesion was located within the popliteal artery and superficial femoral artery.A non-bsc sheath was placed in the tibial artery.The jetstream xc was advanced from the distal to the proximal using atherectomy lubricant, with the intent to activate in the trunk/popliteal segment.Resistance was noted as the jetstream was advanced around the hunter's canal area.At this point, it was decided to remove and upsize the sheath to a standard 7f.After the sheath was exchanged, the jetstream advanced without resistance.After the jetstream use concluded, there was resistance noted upon removal.Once removed from the patient, it was visualized that the coating of the catheter appeared to be delaminating.No further action was taken, as the jetstream was no longer needed at this time.The procedure was completed, and there were no adverse consequences reported for the patient.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16610660
• MDR Text Key: 311947774
• Report Number: 2124215-2023-13055
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0030182387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1