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

Model Number 45007

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919); Positioning Problem (3009)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device returned and evaluated by manufacturer.The device was visually and microscopically examined.Visual examination revealed multiple buckling to the sheath.Microscopic examination revealed no additional damages.A wire insertion test was performed, and the returned guidewire could not pass a severely damaged section.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis found damage that would have contributed to the reported event.

Event Description

It was reported that the jetstream device became stuck on the guidewire.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery (sfa).One pass was made with the jetstream device and it became stuck on a thruway wire.Re-plumbing was attempted; however, the device got stuck on the wire.The wire and catheter were removed from the patient together.Once the device was out of the patient and on the back table, the wire coating was sheared when trying to separate them.No patient complications were reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11845725
• MDR Text Key: 251419398
• Report Number: 2134265-2021-06486
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0026538376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR