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

Model Number	0684-00-0470-01U
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician met resistance while inserting the intra-aortic balloon (iab) through the sheath.The iab was removed and a new one was inserted without further issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation: respiratory therapist (rt).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
Device evaluation: one photograph was provided by the facility.The photograph were analyzed during the evaluation.The product was returned with the membrane completely unfolded and blood was found on the catheter tubing.The sheath was not returned for evaluation.A kink was found on the catheter tubing approximately 75.4cm from the iab tip.Additionally, a bend was found on the inner lumen approximately 25.9cm from the iab tip.The one-way valve and guidewire were also returned.The one-way valve was vacuum tested, and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed, and no leaks were detected.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB WITH ACCESSORIES, US ONLY
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 19973401
• Report Number: 2248146-2024-00498
• Device Sequence Number: 17904382
• Product Code: DSP
• UDI-Device Identifier: 10607567109558
• UDI-Public: (01)10607567109558(10)3000367863(17)270228(11)240228
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 0684-00-0470-01U
• Device Catalogue Number: 0684-00-0470-01U
• Device Lot Number: 3000367863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 86 KG