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

Model Number 45007

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that the catheter could not be operated in forward or reverse gear and was difficult to remove.A 2.4mm, eu jetstream xc atherectomy catheter was selected for use with a non-boston scientific guidewire in an atherectomy procedure.During the procedure, however, the catheter could no longer be operated in the forward or reverse gear.The device was removed from the patient intact and exchanged for another jetstream atherectomy catheter to complete the procedure.There were no patient complications reported.

Event Description

It was reported that the catheter could not be operated in forward or reverse gear and was difficult to remove.A 2.4mm, eu jetstream xc atherectomy catheter was selected for use with a non-boston scientific guidewire in an atherectomy procedure.During the procedure, however, the catheter could no longer be operated in the forward or reverse gear.The device was removed from the patient intact and exchanged for another jetstream atherectomy catheter to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

E1 - initial reporter phone: (b)(6).Device evaluation by mfr.: the returned product consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed and found no damages.Device to device interaction test was performed by inserting a test guidewire through the device.The device was functionally tested by connecting it to a jetstream console.The device was able to prime and run with no issues.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm any issues with the device.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: 16486948
• MDR Text Key: 310718204
• Report Number: 2124215-2023-10120
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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: 0030725621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1