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

Model Number	45006
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jetstream catheter and the wire became stuck.A 1.85 mm jetstream sc atherectomy catheter was selected for treatment of peripheral arterial disease.During the procedure, the jetstream and wire become stuck.The procedure was completed with another jetstream without sequelae.
Additional Manufacturer Narrative
Device eval by manufacturer: this 1.85 mm jetstream sc atherectomy catheter was returned and analyzed.No guidewire was in the device or returned with the device.Visual inspection revealed shaft damage in the form of buckling/kinks located 1 cm from the tip.A.014 test thruway guidewire was inserted into the tip of the device and the guidewire transcended through the device with no hesitations or restrictions.The device was connected to the jetstream console per the instructions for use and was functionally tested for any issues or errors.The device primed as designed.The guidewire was inserted into the gard; however, the device did not function as designed.The motor was heard, but no tip rotation was observed.The devices pod was opened to inspect for damage, which revealed that the pinion gear had slipped off the drive shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The guidewire issues that were observed in the field were not able to be confirmed though analysis.
Event or Problem Description
It was reported that the jetstream catheter and the wire became stuck.A 1.85 mm jetstream sc atherectomy catheter was selected for treatment of peripheral arterial disease.During the procedure, the jetstream and wire become stuck.The procedure was completed with another jetstream without sequelae.

• Brand Name: JETSTREAM SC
• Common Device Name: 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: 18366200
• Report Number: 2124215-2023-72599
• Device Sequence Number: 8015019
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2025
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0031684117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown