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

Model Number 45007

Device Problem Device-Device Incompatibility (2919)

Patient Problem Discomfort (2330)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that catheter blades became stuck on the self-expanding stent.This 2.4mm jetstream xc catheter was selected for use for this atherectomy procedure in the right superficial femoral artery (sfa) for instent restenosis (another manufacturer).During the procedure, the catheter made a couple of successful passes before it became stuck on the third pass.The blades inadvertently stopped, as the catheter got caught on self-expanding stent in the right sfa.The physician had to use a snare and multiple coronary balloons to create a large enough opening to place a covered stent and create adequate flow.The abbott filter basket was irretrievable and had to be compressed between the covered stent and vessel wall.The patient reported discomfort, yet it was noted that patient fully recovered and the procedure was completed successfully.

Event Description

It was reported that catheter blades became stuck on the self-expanding stent.This 2.4mm jetstream xc catheter was selected for use for this atherectomy procedure in the right superficial femoral artery (sfa) for instent restenosis (another manufacturer).During the procedure, the catheter made a couple of successful passes before it became stuck on the third pass.The blades inadvertently stopped, as the catheter got caught on self-expanding stent in the right sfa.The physician had to use a snare and multiple coronary balloons to create a large enough opening to place a covered stent and create adequate flow.The abbott filter basket was irretrievable and had to be compressed between the covered stent and vessel wall.The patient reported discomfort, yet it was noted that patient fully recovered and the procedure was completed successfully.Additional information was received that the jetstream was successful upon first pass at treating the instent restenosis.More details were given regarding when the jetstream device came in contact with a metal strut from the stent; latched onto the stent and twisted the stent into one focal point at the end of the stent.The physician had to reopen in the focal area with a wire and then systematically use the smallest coronary balloon to create a larger hole to provide for larger coronary balloons to be inflated to create a large enough area for the gore covered stent catheter to pass through the segment and then be deployed.Once it was deployed, it was covering the remaining segment of the filter.

• 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: 15587123
• MDR Text Key: 301564056
• Report Number: 2124215-2022-37753
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029524951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White