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

Model Number	45010
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a failure to aspirate.A 2.1mm jetstream xc catheter and a jetstream console were selected for use in a lower extremity atherectomy procedure to treat peripheral vascular disease.The catheter was opened and primed as usual.The catheter was introduced into the artery for atherectomy.Upon activation, it was noted that there were no aspiration contents.The catheter was removed and re-primed.A second attempt was made, but the device still did not aspirate.Another device was used to complete the procedure.No patient complications were reported.It was noted that aspiration difficulties and taking too long to prime have been ongoing issues with this console.
Additional Manufacturer Narrative
H3 - device evaluated by manufacturer: the jetstream was returned for investigation.There was physical damages on the console rear panel, both mounting holes on the rear panel were cracked.The damages did not affect the functionality of the console.The jetstream was functionally tested and passed.The jetstream was left on for an hour and the functional test was repeated.There was no issue observed.The aspiration function performed normally with a normal fluid volume in the waist bag.The catheter primed normally for both tests.The reported, 'no aspiration' was not replicated.
Event or Problem Description
It was reported that there was a failure to aspirate.A 2.1mm jetstream xc catheter and a jetstream console were selected for use in a lower extremity atherectomy procedure to treat peripheral vascular disease.The catheter was opened and primed as usual.The catheter was introduced into the artery for atherectomy.Upon activation, it was noted that there were no aspiration contents.The catheter was removed and re-primed.A second attempt was made, but the device still did not aspirate.Another device was used to complete the procedure.No patient complications were reported.It was noted that aspiration difficulties and taking too long to prime have been ongoing issues with this console.

• Brand Name: JETSTREAM PVCN100
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11900628
• Report Number: 2134265-2021-06943
• Device Sequence Number: 14364635
• Product Code: MCW
• UDI-Device Identifier: 08714729890430
• UDI-Public: 08714729890430
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 08/07/2025
• Device Model Number: 45010
• Device Catalogue Number: 45010
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR