MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 25CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-01U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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 during intra-aortic balloon (iab) therapy, a leak occurred and blood was seen in the tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The alarm history of the console showed several catheter alarms that are related to a catheter that had a minor leak.The alarms included auto-fill failure, iab disconnected, and iab catheter restriction.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field d10 returned to manufacturer on to: 08/17/2021.On 29nov2021, the customer confirmed that the returned product was for this event.It was initially returned from the facility identified as being for a different event.Device evaluation: the product was returned with the membrane completely unfolded with blood on the exterior, between the catheter and sheath, and within the catheter tubing, extracorporeal tubing, and membrane.An occlusion was found in the inner lumen which was not cleared.A sheath was returned attached to the catheter at approximately 16.764cm from the iab tip and partially covering the balloon membrane.The catheter tubing was also cut at approximately 46.482cm from the iab tip.An inner lumen and catheter tubing kink was found at approximately 29.972cm from the iab tip.Breakage of the inner lumen and catheter tubing was also observed at this location.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and one leak was detected at the region of the inner lumen/catheter tubing breakage.The evaluation confirmed the reported leak.A severe kink or continuous flexing of a kink can cause the catheter and inner lumen to break resulting in a leak and alarms to trigger.It is difficult to determine when or how a kink in the catheter and inner lumen occurs.The evaluation did not confirm any alarms.We were unable to replicate the failures in the laboratory setting.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Complaint record id #: (b)(4).

• Brand Name: LINEAR 7.5 FR. 25CC 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: 12424760
• Report Number: 2248146-2021-00578
• Device Sequence Number: 14548239
• Product Code: DSP
• UDI-Device Identifier: 10607567109480
• UDI-Public: 10607567109480
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 12/01/2023
• Device Model Number: 0684-00-0478-01U
• Device Catalogue Number: 0684-00-0473
• Device Lot Number: 3000137764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: CARDIOSAVE / (B)(6).
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 69 KG