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

Model Number	0684-00-0296-02
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the customer had two intra-aortic balloons (iab) that had malfunctioned.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
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.The report for "insufficient failure information" is operating within its risk profile.A labeling review is not able to be completed since a specific failure was not reported.There were no ncmrs identified from the ship history which could cause or contribute to the reported event.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
Event or Problem Description
It was reported that the customer had two intra-aortic balloons (iab) that had malfunctioned.There was no patient harm or adverse event reported.

• Brand Name: MEGA 8FR. 50CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11371958
• Report Number: 2248146-2021-00127
• Device Sequence Number: 14398328
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: 10607567108018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K091449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 02/05/2023
• Device Model Number: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000114163
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1