MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC DILATOR/SHEATH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0403-10
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy on a stemi patient, the sheath cracked by the transition point.The dilator snapped causing the main dilator to stay in the sheath.Dr.(b)(6) indicated counterpulsation therapy was intended to assist with resuscitation efforts, confirming the getinge iab was intended to be inserted in a femoral artery with arterial access.The device was reported to be without obvious defect upon removal from kit, and assembly of the sheath dilator into the getinge provided sheath was uneventful.Femoral access was obtained and sheath/dilator assembly was passed over the wire without event.When removing the dilator and wire together, dr.O¿cochlain discovered that only the dilator hub remained on the wire, the distal portion of the dilator remaining within the sheath.Attempts to pass a wire to retrieve the dilator remaining within the sheath were unsuccessful.There was reportedly some patient movement during the procedure but timing or severity of the movement could not be confirmed.Dr.O¿cochlain confirmed vessel injury did occur, described as ¿internal iliac dissection¿, the tip of the dilator making contact with the vessel wall.Dr.O¿cochlain confirmed the injury was managed medically, and the flow distal to the dissection was not impacted.The dilator was subsequently removed with the sheath (together), but as the arterial access was lost, an alternative iab was placed in the opposing femoral artery.
Additional Manufacturer Narrative
Initial reporter full name: (b)(6), mba, rn, nurse manager additional reporter: dr.(b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).
Additional Manufacturer Narrative
The introducer dilator and sheath were returned with the dilator tubing inside the sheath with dried blood on the components.The hub of the dilator was found broken off from the dilator tubing.The sheath and the returned dilator were measured and found to be within specification.The sheath was observed to be intact with no defects.No other visual defects were identified.The evaluation confirms the reported problem with the dilator.The root cause of the issue at this time is impossible to define.Capa 830128 has been initiated to investigate this issue further and identify a root cause.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC DILATOR/SHEATH
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16903383
• Report Number: 2248146-2023-00322
• Device Sequence Number: 17507447
• Product Code: DSP
• UDI-Device Identifier: 10607567107943
• UDI-Public: 10607567107943
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 10/06/2025
• Device Model Number: 0684-00-0403-10
• Device Catalogue Number: 0684-00-0403-10
• Device Lot Number: 3000258553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG