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

Model Number	0684-00-0480-02
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
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 prior to insertion, the intra-aortic balloon (iab) did not deflate properly and could not be inserted.A new iab was used, but the same issue occurred.A third iab was successfully inserted to continue therapy.There was no patient harm or adverse event reported.This report is for the 1st iab.A separate report will be submitted for the 2nd iab.
Event or Problem Description
It was reported that prior to insertion, the intra-aortic balloon (iab) did not deflate properly and could not be inserted.A new iab was used, but the same issue occurred.A third iab was successfully inserted to continue therapy.There was no patient harm or adverse event reported.This report is for the 1st iab.A separate report has been submitted for the 2nd iab under mfg report number 2248146-2022-00838.
Additional Manufacturer Narrative
The product was returned with the membrane loosely folded and blood found on the exterior of the catheter.A kink was found on the catheter tubing approximately 32.0 cm from the iab tip.The inner lumen was found to be occluded.The occlusion was unable to be cleared.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.The iab was placed on the cs300 pump and the iab fully inflated and deflated.No alarm sounded from the pump.The reported difficult deflation cannot be confirmed by the evaluation.Additionally 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.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: 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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 15663547
• Report Number: 2248146-2022-00830
• Device Sequence Number: 6461520
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: 10607567106571
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 11/29/2024
• Device Model Number: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000208097
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown