MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01U
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi # (b)(4) is incomplete as the lot # and manufacture date were not provided.This information was requested from the customer.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
Event or Problem Description
It was reported that during insertion, the intra-aortic balloon (iab) was unable to be inserted through the included 8fr sheath.After several attempts, they opted to switch the sheath to a pinnacle 8 fr sheath.This was successful and therapy was provided.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Patient demographics updated.Reference complaint #(b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and no blood was found on the exterior.The sheath was not returned for evaluation.Two kinks were found on the catheter tubing approximately 76.2cm and 71.6cm from iab tip.Additionally, an inner lumen kink was found approximately 76.2cm from the iab tip.The one-way valve was returned for evaluation.- a laboratory insertion test was unable to be performed due to the membrane being unfurled.- the one-way valve was vacuum tested, and it held vacuum.- an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed, and no leaks were detected.The reported failure of ¿difficult.Unable to insert iab through sheath¿ was mostly triggered by an inner lumen kink found on the balloon catheter tubing.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).
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
• 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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 20442159
• Report Number: 2248146-2024-0000626
• Device Sequence Number: 7990620
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(10)3000300894(17)260420(11)230301
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• 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,Followup
• Report Date (Section B): 11/19/2024

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 Expiration Date: 04/20/2026
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000300894
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 11/12/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/17/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PINNACLE 8 FR SHEATH.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG