MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-08
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 after inserting the intra-aortic balloon (iab) a leak occurred.The iab was removed and replaced with a new one.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 device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period apr-19 through mar-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text : device not returned.
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab) a leak occurred.The iab was removed and replaced with a new one.There was no patient harm or adverse event reported.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11607253
• Report Number: 2248146-2021-00214
• Device Sequence Number: 3280585
• Product Code: DSP
• UDI-Device Identifier: 10607567109725
• UDI-Public: 10607567109725
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 11/15/2022
• Device Model Number: 0684-00-0480-08
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000108623
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60