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

Model Number 45007

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Difficult to Remove (1528); Noise, Audible (3273); Unexpected Shutdown (4019)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that the catheter became entrapped on the guidewire.A 2.1mm jetstream xc atherectomy catheter was selected for procedure to treat peripheral artery disease in the superficial femoral artery.The jetstream catheter was used with a non-boston scientific filter wire.During the procedure, about 7 minutes into using the device in the blades up mode, the jetstream catheter made a high pitched squeal and grinding noise, and the device stopped working.It wouldn't work still after pressing any button on the console.The device was reset and reprimed to wet the filter wire, but the issue was not resolved.The console was noted to be displaying an error message.The jetstream catheter and the filter wire were able to be removed together as one unit, though it was very difficult.After removal, the filter wire was observed to have a kink in it.The atherectomy procedure was completed with this device.There were no patient complications reported.

Manufacturer Narrative

Device evaluation by mfr.: returned product consisted of a jetstream xc-2.1.The non-boston scientific filter wire was in the device when returned.The device and the catheter shaft were analyzed for damage.Visual and microscopic examination showed buckling/kink located 1cm from the tip.The device also showed a burst infusion sheath located approximately 20cm from the tip.The device was set up per the instructions for use (ifu) and the device primed and ran as designed.The device showed a filter guidewire stuck in the guidewire lumen.The guidewire was sticking out of the tip approximately 142.5cm and sticking out of the pod end 22cm.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was confirmed for guidewire sticking due to the non-compatible guidewire used.

Event Description

It was reported that the catheter became entrapped on the guidewire.A 2.1mm jetstream xc atherectomy catheter was selected for procedure to treat peripheral artery disease in the superficial femoral artery.The jetstream catheter was used with a non-boston scientific filter wire.During the procedure, about 7 minutes into using the device in the blades up mode, the jetstream catheter made a high pitched squeal and grinding noise, and the device stopped working.It wouldn't work still after pressing any button on the console.The device was reset and reprimed to wet the filter wire, but the issue was not resolved.The console was noted to be displaying the err1 error message.The jetstream catheter and the filter wire were able to be removed together as one unit, though it was very difficult.After removal, the filter wire was observed to have a kink in it.The atherectomy procedure was completed with this device.There were no patient complications reported.

• 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: 15480643
• MDR Text Key: 303728484
• Report Number: 2124215-2022-36735
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027799553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1