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 08/23/2023

Event Type  malfunction  

Event Description

It was reported that aspiration was lost.This 2.4mm jetstream xc catheter was selected for use in a lower extremity angiogram procedure for peripheral artery disease.After approximately four minutes of run time, after three passes in blades down mode, and during the fourth pass in blades up mode halfway through the occlusion, aspiration appeared to be lost as if the catheter was clogged.Device suction could be heard; however, no bodily fluid or saline was being returned.Troubleshooting was performed but was unable to resolve the issue.The procedure was completed with another of the same device.There were no patient complications.

Event Description

It was reported that aspiration was lost.This 2.4mm jetstream xc catheter was selected for use in a lower extremity angiogram procedure for peripheral artery disease.After approximately four minutes of run time, after three passes in blades down mode, and during the fourth pass in blades up mode halfway through the occlusion, aspiration appeared to be lost as if the catheter was clogged.Device suction could be heard; however, no bodily fluid or saline was being returned.Troubleshooting was performed but was unable to resolve the issue.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the lesion was located in the mid-superficial femoral artery and was 100% occluded with mixed morphology.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this jetstream xc catheter was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.Functional analysis was done by completing the setup procedure per the instructions for use.Aspiration testing of the device was done per the test procedure.Test results showed that this device did not perform as designed per the test procedure specification sheet.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was confirmed for evacuation failure.

Event Description

It was reported that aspiration was lost.This 2.4mm jetstream xc catheter was selected for use in a lower extremity angiogram procedure for peripheral artery disease.After approximately four minutes of run time, after three passes in blades down mode, and during the fourth pass in blades up mode halfway through the occlusion, aspiration appeared to be lost as if the catheter was clogged.Device suction could be heard; however, no bodily fluid or saline was being returned.Troubleshooting was performed but was unable to resolve the issue.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the lesion was located in the mid-superficial femoral artery and was 100% occluded with mixed morphology.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17611549
• MDR Text Key: 321833025
• Report Number: 2124215-2023-45702
• 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,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 0032005964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1