MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR 40CC IAB WITH ACCESSORIES (TURKEY); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-09
Medical Device Problem Codes	Overheating of Device (1437); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that during intra aortic balloon therapy (iab) "fiber optic sensor failure" warning appeared on the screen.The user's reason for calling was the "no pressure source available" warning.There was no patient harm/injury reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person ¿ mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation conclusions), h11 corrected fields: h6 (investigation findings, medical device ¿ problem code) no decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.Complaint id: (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: d4 (udi no., lot no.) the iab was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.The optical fiber was found to be broken within the catheter tubing approximately 37.8cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint id no.: (b)(4).

• Brand Name: SENSATION 7FR 40CC IAB WITH ACCESSORIES (TURKEY)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21156927
• Report Number: 2248146-2025-0000028
• Device Sequence Number: 8399521
• Product Code: DSP
• UDI-Device Identifier: 10607567113135
• UDI-Public: (01)10607567113135(10)3000367226(17)270222(11)240222
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2025

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: 0684-00-0470-09
• Device Catalogue Number: 0684-00-0470-09
• Device Lot Number: 3000367226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2024
• Supplement Date Received by Manufacturer: 02/18/2025; 03/07/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/21/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown