MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Codes	Restricted Flow rate (1248); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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).
Event or Problem Description
It was reported that upon insertion of the intra-aortic balloon (iab), it was unable to augment and a catheter restriction alarm was generated.There were no kinks found along the iab catheter or extracorporeal helium tubing.A new iab was then inserted to provide therapy without further issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.Additionally no visible damage was observed on the returned catheter.Photos of the returned contents was also provided.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated and deflated.The iab then pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.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).
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Complaint record id # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC IAB
• 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: 19760993
• Report Number: 2248146-2024-00436
• Device Sequence Number: 8725439
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000349897(17)261117(11)231117
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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 Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000349897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 11/19/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/09/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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.
• Patient Sex: Unknown