MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	45016
Medical Device Problem Codes	Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure cancellation occurred.A jetstream pvcn100 console was being used in the index procedure when it alarmed with the error 1 code.The procedure could not be completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: jetstream console serial number s/n (b)(6) was returned for investigation.Visual inspection shows no damage to console.The console was tested per functional test procedure.An error2 code occurred after priming.Troubleshooting determined that error2 was caused by the defective component inside the pump assembly.The original pump assembly was replaced with the gold pump assembly, and functional test was retested.All test passed.Error1 is relating to error2, therefore, the complaint is confirmed.
Event or Problem Description
It was reported that a procedure cancellation occurred.A jetstream pvcn100 console was being used in the index procedure when it alarmed with the error 1 code.The procedure could not be completed.There were no patient complications reported.

• Brand Name: JETSTREAM PVCN100
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14788715
• Report Number: 2134265-2022-07195
• Device Sequence Number: 14897873
• Product Code: MCW
• UDI-Device Identifier: 08714729890454
• UDI-Public: 08714729890454
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130637
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: 45016
• Device Catalogue Number: 45016
• Device Lot Number: 1101-1564
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male