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	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jetstream became stuck on the guidewire.A jetstream sc catheter, 1.6mm was selected for use during an infrapopliteal atherectomy procedure.During the procedure, the catheter became stuck on a thruway 0.014 x 300cm wire.The jetstream and thruway wires were removed together from the patient.No patient complications were reported.
Event or Problem Description
It was reported that the jetstream became stuck on the guidewire.A jetstream sc catheter, 1.6mm was selected for use during an infrapopliteal atherectomy procedure.During the procedure, the catheter became stuck on a thruway 0.014 x 300cm wire.The jetstream and thruway wires were removed together from the patient.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned and evaluated by the manufacturer: the returned product consisted of a jetstream sc-1.6.The guidewire was not in the device or returned with the device.The catheter shaft showed no damage.The device was set up per the instructions for use and the device primed and functioned as designed.A.014 thruway test guidewire was attempted to be inserted into the guidewire tip of the device and the wire would not pass the tip.The tip was removed from the catheter shaft and showed an extreme clot and contrast burden.The clot and contrast were dried and extremely hard.There was also a foreign material noticed in the distal cutter tip.The foreign material was analyzed using fourier-transform infrared spectroscopy (ftir) testing and was found to be fluorocarbon material.This material is found in many devices internal lumens such as introducer sheaths and microcatheters.It is possible that the jetstream device was run inside the lumen of another device and cut and aspirated the lumen wall which caused the foreign material in the cutter tip.With the extreme clot and contrast burden along with the foreign material found this may all have contributed to the guidewire sticking issues the customer experienced.The complaint was confirmed for a restriction on the guidewire due to the extremely occluded catheter distal tip.

• Brand Name: JETSTREAM SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12230289
• Report Number: 2134265-2021-09441
• Device Sequence Number: 17094311
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 06/27/2022
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0025771082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1