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

Model Number	0684-00-0479-02U
Medical Device Problem Codes	No Display/Image (1183); Inflation Problem (1310); Leak/Splash (1354); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy on an orthotopic heart transplant patient, the waveform was difficult to monitor, and the iab was not inflating.Approximately five minutes into therapy, blood was seen in the gas line.The console was placed on standby, and the iab was replaced.There was no patient harm, or adverse event reported.
Additional Manufacturer Narrative
Section d: changed serial number from (b)(6) to (b)(6).Section h: changed evaluation result codes (1) from 1310 to 1183.Device evaluation: the iab was returned cut in two parts with the membrane completely unfolded and blood on the interior and exterior of the catheter.Visual examination confirmed that both tip and rear markers were in place per specification.Photos were also provided of the iab.An underwater leak test of the catheter, y-fitting and extracorporeal tubing was performed but the leak could not be located.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.The evaluation determined an occlusion in the inner lumen.This can cause difficulty monitoring the waveform.We are unable to determine how this may have occurred.The returned device was inspected and found to have tantalum markers in place per specification.We are unable to determine the cause of the reported difficult to view complaint since we cannot mimic the clinical setting or patient anatomy.The evaluation determined no leaks found.However we were unable to conclusively determined a leak due to the returned condition of the device.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy on an orthotopic heart transplant patient, the waveform was difficult to monitor and the iab was not inflating.Approximately five minutes into therapy, blood was seen in the gas line.The console was placed on standby and the iab was replaced.There was no patient harm or adverse event reported.

• 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 07004
• MDR Report Key: 10710668
• Report Number: 2248146-2020-00551
• Device Sequence Number: 3259660
• Product Code: DSP
• UDI-Device Identifier: 10607567109510
• UDI-Public: 10607567109510
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 11/12/2022
• Device Model Number: 0684-00-0479-02U
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000108621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTOCAT WAVE 2 CONSOLE; AUTOCAT WAVE 2 CONSOLE
• Patient Age: 22 YR
• Patient Weight: 64