MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that troubleshooting was unable to resolve the alert.If the patient is brought back to the catheterization lab for catheter replacement, this is considered an additional intervention.A 135x50cm ekosonic endovascular device was selected for a left lower extremity deep vein thrombosis (dvt) procedure.Therapy run time was 19 minutes and 30 seconds.During the procedure, a red alarm e311 was displayed on the screen.All connections were verified to be secure.No bent pins or fluid ingress was observed.The connector interface cable (cic) was switched to a different channel and switched to a new cic; however, there was no resolution.The capital equipment was switched to a new one but the same alarm occurred.The patient was in pain, and was brought back to the catheterization lab for device replacement.
Additional Manufacturer Narrative
Correction: b2: corrected from other serious (important medical events) to required intervention to prevent permanent impairment/damage.B5: describe event or problem: clarification of initial reported information.H6: patient codes (1): changed from pain to no clinical signs, symptoms or conditions.
Event or Problem Description
It was reported the patient returned to the catheterization lab for a catheter replacement.A 135x50cm ekosonic endovascular device was selected for a left lower extremity deep vein thrombosis (dvt) procedure.Therapy run time was 19 minutes and 30 seconds.During the procedure, a red alarm e311 was displayed on the screen.All connections were verified to be secure.No bent pins or fluid ingress was observed.The connector interface cable (cic) was switched to a different channel and switched to a new cic; however, there was no resolution.The capital equipment was switched to a new one but the same alarm occurred.The patient was in pain, and was brought back to the catheterization lab for device replacement.It is further clarified that this patient initially presented to the cath lab in pain.The reported pain was not a new complication associated with the device or procedure.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14915152
• Report Number: 2134265-2022-07487
• Device Sequence Number: 14996388
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035058888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown