MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, CONTINUOUS FLUSH

Model Number	109681-001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Angiojet equipment primed by rn prior to use of angiojet.When cassette placed in machine and door closed to load the cassette, machine did not recognize cassette.Door reopened and cassette reseated.Door closed and machine still did not recognize cassette in order to continue with priming.Door reopened and when cassette was visually examined, rn noted that something appeared different and, upon closer examination of "balloon" at top of metal plunger, a fluid leak was noted and small puncture was visible.Entire angiojet assembly was immediately removed from field and machine; replaced with new angiojet product which then immediately worked, priming correctly and no further difficulties were encountered for the rest of the case.Defective product was never loaded onto guidewire or inserted into patient prior to removal.Fda safety report id # (b)(4).

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; maple grove MN 55311
• MDR Report Key: 13019456
• Report Number: MW5106092
• Device Sequence Number: 1893913
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 0108714729889663172307091027941
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: 07/09/2023
• Device Model Number: 109681-001
• Device Catalogue Number: CE 2797
• Device Lot Number: 27941139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic