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

Model Number 45007

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.A spider filter wire was stuck in the device.The device and the catheter shaft were analyzed for damage.Visual examination showed buckling/kink located 1cm from the tip and 12.5cm from the tip.A non-bsc filter guidewire was stuck in the device.The wire was sticking out of the tip approximately 21.5cm and sticking out of the pod approximately 144cm.The device was set up per the ifu and the device primed; however, the rotation f the tip was slow and labored.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for guidewire sticking and shaft damage.

Event Description

It was reported that guidewire entrapment occurred.A 2.1 mm jetstream xc catheter was selected for peripheral intervention of the superficial femoral artery (sfa) to treat peripheral arterial disease (pad).A 6 mm non-boston scientific guidewire was used with atherectomy lubricant.The device was primed and attempted to advance blades down and rex.An attempt was made to retract on rex over the wire.The device and wire were removed together through manual retraction.The device could not rotate due to the guidewire entrapment.There were no patient complications reported.

• Brand Name: JETSTREAM XC
• 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: 18996940
• MDR Text Key: 339147436
• Report Number: 2124215-2024-18566
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 0032670737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: Black Or African American