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

Model Number	0684-00-0295-02
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that after approximately eight days of intra-aortic balloon (iab) therapy, blood specs were noted in the extracorporeal tubing.The console was turned off.The iab was removed approximately one hour later.The customer had difficulty removing the iab.Cardiology advised to continue removing gently until the iab came out, removing the sheath and iab at same time.Fem stop was applied and the patient lost pulses.The patient was sent to surgery for thrombectomy and endarterectomy of the right leg.Patient lost pulses again and went back for redo thrombectomy.Approximately 42 hours after removing the iab, withdrawal of life support was performed.The patient expired due to multi-organ failure and acute cellular rejection.The customer did not attribute patient expiration to the iab.
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).Device not returned.
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 completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and covering half of the balloon.The returned sheath was not a maquet product.The extender tubing was also returned.The sheath tubing was found to be kinked at the proximal and distal end.Additionally the inner lumen was found stretched within the membrane along its length.A kink was found on the catheter tubing near the y-fitting approximately 77.2cm fromt the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.013cm in length.The evaluation confirmed the reported leak and difficulty to remove iab.Blood filled into the penetration of the membrane causing difficult removal of the iab.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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).
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 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: 14778447
• Report Number: 2248146-2022-00489
• Device Sequence Number: 14676471
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: 10607567107981
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2022

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: 12/20/2024
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000213247
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 08/16/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/20/2022; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: AUTOCAT 2 WAVE CONSOLE S/N (B)(6).
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 55 KG