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

Model Number 45007

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

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually and microscopically examined for any shaft damage.Visual examination showed a kink on the catheter shaft located 1cm from the tip and a severe kink located 69.5cm from the tip.The device was set-up and functionally tested per the instructions for use.The device primed and ran as designed.It was noticed that the catheter shaft leaked fluid from the kink at the 69.5cm location.Testing the device in the anatomical was not possible due to the damage on the catheter shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 17aug2023.It was reported that difficulty advancing occurred.A 2.1mm jetstream xc atherectomy catheter was selected for the atherectomy procedure.During the advancement over the non-boston scientific wire, however, the jetstream catheter was not able to move forward.The rex function was possible, and the catheter was removed intact.Upon removal, there was a visible bend directly behind the blades of the catheter.The device was replaced with a new jetstream catheter to complete the procedure.No patient complications were reported.However, device analysis revealed the infusion line was leaking.

• 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: 17662335
• MDR Text Key: 322410868
• Report Number: 2124215-2023-45684
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2023

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: 0030706926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1