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

Model Number 45007

Device Problem Suction Problem (2170)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported that aspiration was lost.The 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure.The catheter was primed well; however, aspiration stopped working mid-procedure.Attempts were made to reprime the device, but there was still no aspiration.The catheter was removed, and an additional catheter of the same kind was used to complete the procedure.There were no patient complications.The product is expected to be returned.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 2.4mm jetstream xc catheter was visually examined for any shaft damage and the functional testing of the device was completed.No damage was noticed on the device.Functional analysis was done by completing the setup procedure per the instructions for use.The device primed and the blades rotated as designed.Aspiration testing of the device was done per standard testing procedures.The device tip was submerged in a beaker of fluid and the device was run for a period of one minute to determine the aspiration amount.Test results showed that this device performed as designed per the test procedure specifications, withdrawing 40ml of fluid in the one minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for evacuation issues.

Event Description

It was reported that aspiration was lost.The 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure.The catheter was primed well; however, aspiration stopped working mid-procedure.Attempts were made to reprime the device, but there was still no aspiration.The catheter was removed, and an additional catheter of the same kind was used to complete the procedure.There were no patient complications.The product is expected to be returned.

• 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: 16140752
• MDR Text Key: 308490036
• Report Number: 2124215-2023-00953
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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,Followup
• Report Date: 01/26/2023

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: 0030444605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1