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 Codes	Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: administrator/ supervisor.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).Device not returned.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a balloon rupture occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Upon removal, it was noted that the ruptured iab was crumpled and became difficult to remove.The patient required a larger incision to remove the iab.A new iab was inserted to continue therapy.
Additional Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id #(b)(4).
Additional Manufacturer Narrative
The product was returned with the membrane ruptured with heavy blood in the membrane, on the exterior, extracorporeal tubing, between the sheath and catheter tubing.The sheath was returned at approximately 1.2cm from the iab tip and covered ¾ of the balloon.The sheath was unable to be removed from the iab.The inner lumen was broken at approximately 26.6 cm from the iab tip.An underwater leak test of the catheter, y-fitting, extracorporeal tubing, was performed and no leaks were detected.A leak test of the membrane and inner lumen was unable to be performed.A 0.0025¿ guidewire was inserted and the inner lumen was found to be occluded with blood and unable to be cleared.The evaluation confirmed the reported problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the reported failure.A non-conforming material report 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
• 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: 13523594
• Report Number: 2248146-2022-00112
• Device Sequence Number: 4474026
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: 10607567108018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091449
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 12/27/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/09/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown