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

Model Number 45007

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Device Displays Incorrect Message (2591); Air/Gas in Device (4062)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/02/2022

Event Type  Injury  

Event Description

It was reported that a pseudoaneurysm occurred after atherectomy.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure to treat a total occlusion.The vessel was mildly tortuous.The catheter made several passes through the lesion.While attempting another pass through the lesion, in blades up mode, it was noted there was difficulty advancing the device.The physician attempted to rex the device backwards.However, a bubl and tube error occurred.They attempted to restart the entire system, but it was unsuccessful.The catheter was attempted to be removed; however, it was stuck on the non-bsc guidewire.The guidewire and catheter were removed together.After atherectomy, a pseudoaneurysm was observed.A non-bsc stent was placed on december 12 to treat the pseudoaneurysm.There were no further patient complications.

Manufacturer Narrative

Device eval by manufacturer: the returned product that was received consisted of a jetstream xc-2.1 atherectomy catheter.No guidewire was returned in or with the device.The device was visually and microscopically inspected for damage.The shaft showed no damage.The set up was conducted using the instructions per the instructions for use.The device primed as designed.The device functioned as designed for a period of 2 minutes with no issues or errors.The setup was repeated multiple times with the same outcome, no bubble, or tubing errors.A.014 thruway guidewire was attempted to be inserted into the devices tip.The wire passed into the device approximately 4cm and stopped.The devices tip was dissected to verify any reason that the wire would not transcend.No obstruction was noticed.The shaft was dissected, and it was noticed that there was clot and coating from the guidewire occluding the guidewire lumen.Inspection of the remainder of the device revealed no damage or irregularities.The complaint for a bubble/tubing errors was not confirmed; however, guidewire sticking was confirmed.

Event Description

It was reported that a pseudoaneurysm occurred after atherectomy.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure to treat a total occlusion.The vessel was mildly tortuous.The catheter made several passes through the lesion.While attempting another pass through the lesion, in blades up mode, it was noted there was difficulty advancing the device.The physician attempted to rex the device backwards.However, a bubble and tube error occurred.They attempted to restart the entire system, but it was unsuccessful.The catheter was attempted to be removed; however, it was stuck on the non-bsc guidewire.The guidewire and catheter were removed together.After atherectomy, a pseudoaneurysm was observed.A non-bsc stent was placed on december 12 to treat the pseudoaneurysm.There were no further patient complications.

• 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: 16035319
• MDR Text Key: 306008106
• Report Number: 2124215-2022-52108
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0030086282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention