MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01C
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after approximately two days of intra-aortic balloon (iab) therapy the console generated a check iab catheter alarm.The customer checked the iab but found no issue.Two hours later, the console generated the same alarm and blood was seen in the tubing.The iab had to be removed by surgery in the intensive care unit (icu).There was no patient harm or adverse event reported.
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).
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).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
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.A kink was found on the catheter tubing approximately 59.7cm from the iab tip.Additionally a second kink was found on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and six leaks were detected on the membrane.One abrasion leak at approximately 1.8cm from the rear seal and measuring 0.013cm in length.Five sharp edge leaks ranging from 2.5cm to 7.4cm from the rear seal and measuring ranging from 0.127cm to 0.635cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.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.The other five penetrations found appear to have been caused by a sharp object that may have occurred during iab removal.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. 34CC 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: 14022386
• Report Number: 2248146-2022-00280
• Device Sequence Number: 2632971
• Product Code: DSP
• UDI-Device Identifier: 10607567109329
• UDI-Public: 10607567109329
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 07/22/2022

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: 07/14/2024
• Device Model Number: 0684-00-0479-01C
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000179632
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/01/2022; 07/22/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/18/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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: UNKNOWN PUMP.
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG