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

Model Number 45007

Device Problems Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 08/08/2023

Event Type  Injury  

Event Description

It was reported that the infusion line burst, and the device was difficult to remove.Additionally, a thrombosis was detected after use, so an medication and an additional device were required.A 2.4mm jetstream xc atherectomy catheter was selected for the atherectomy procedure to treat peripheral arterial occlusive disease in the superficial femoral artery.During use, however, it appeared that the infusion line casing had come loose, but there were no irregular noises noticed.The device was used to complete the procedure, but upon removal, it was difficult to retrieve the jetstream xc atherectomy catheter.The catheter was eventually able to be removed intact; however, there was a small embolism below the treated lesion and above the inserted non-boston scientific filter.After the addition of a local lysis drug, the thrombus could be dissolved and removed with a non-boston scientific catheter.The patient had no abnormalities after the operation and also on the day of discharge.The patient had fully recovered.

Event Description

It was reported that the infusion line burst, and the device was difficult to remove.Additionally, a thrombosis was detected after use, so an additional device was required.A 2.4mm jetstream xc atherectomy catheter was selected for the atherectomy procedure to treat peripheral arterial occlusive disease in the superficial femoral artery.During use, however, it appeared that the infusion line casing had come loose, but there were no irregular noises noticed.The device was used to complete the procedure, but upon removal, it was difficult to retrieve the jetstream xc atherectomy catheter.After successfully removing the catheter intact, a local thrombosis was observed distal to the miller machine with an inconspicuous spider noticeable.A local lysis was performed with a non-boston scientific catheter to remove the thrombosis.No additional complications were reported, and the patient had fully recovered.

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of a jetstream sc-1.85 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no shaft damage.The bag spike was removed from the customer site.A test bag spike was used to complete testing of the device.The device was set-up and tested per the instructions for use (ifu).The device primed and ran as designed.An aspiration test was conducted noting that there was fluid being removed and going into the waste bag.Aspiration testing of the device was done per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml-85ml=13ml).The minimum amount of fluid that is aspirated per the test procedure specification sheet is 11ml per minute and the maximum is 21ml per minute.Test results showed that this device did perform as designed per the test procedure specification sheet withdrawing 15ml of fluid in the 1minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.Aspiration issues or damage to the device were not confirmed.

• 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: 17672022
• MDR Text Key: 322529003
• Report Number: 2124215-2023-47129
• 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,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0031999266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention