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

Model Number 45007

Device Problems Suction Problem (2170); Mechanical Jam (2983)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that the jetstream catheter lost suction.A 2.4mm jetstream xc atherectomy catheter was selected to treat peripheral arterial disease.During the procedure, after six minutes, the catheter lost suction.There was no error message associated.The catheter was flushed to try to troubleshoot the issue, however, then the catheter was unable to advance over the.014 thruway guidewire.The procedure was continued without the use of another atherectomy device.No patient complications were reported.

Event Description

It was reported that the jetstream catheter lost suction.A 2.4mm jetstream xc atherectomy catheter was selected to treat peripheral arterial disease.During the procedure, after six minutes, the catheter lost suction.There was no error message associated.The catheter was flushed to try to troubleshoot the issue, however, then the catheter was unable to advance over the.014 thruway guidewire.The procedure was continued without the use of another atherectomy device.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a 2.4mm jetstream xc atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.Visual inspection revealed no shaft damage.The guidewire was inserted into the tip of the catheter shaft and the wire transcended through the device with no hesitations or restrictions.The device primed and ran.Aspiration testing of the device was completed, and the test results revealed that this device performed as designed per the test procedure specification sheet.Inspection of the remainder of the device revealed no damage or irregularities.Analysis was not able to confirm the aspiration issues or guidewire restrictions reported from the field.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18538709
• MDR Text Key: 333173908
• Report Number: 2124215-2024-02535
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028747055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THRUWAY .014; THRUWAY .014