MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01

Device Problems Restricted Flow rate (1248); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(6).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 Description

It was reported that during intra-aortic balloon(iab) therapy, the console generated a iab catheter restriction alarm, and the iab was unable to inflate fully.The iab was removed.The customer used a 50cc syringe to test and inflate the iab.More force was applied and a pop sound was heard and the iab was then able to fully inflate.They noticed that certain part of the balloon was still folded and not fully inflated.A new iab was inserted to continue therapy.There was no reported adverse event or injury to the patient.

Manufacturer Narrative

Serial number from: unknown to: (b)(6).Device evaluation: the product was returned with the membrane completely unfolded with no visible blood on the exterior of the catheter.A catheter tubing/inner lumen kink was observed at approximately 1cm from the y-fitting.Additionally, a flat catheter tubing section was also observed at approximately 1.8cm from the membrane rear seal.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump for two hours, which represents one complete autofill cycle.The iab pumped normally and no alarm sounded.The reported event cannot be confirmed by the evaluation.However, kinks on the catheter tubing could cause alarms and/or difficulty inflating the iab.We were unable to duplicate the reported event.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 Description

It was reported that during intra-aortic balloon(iab) therapy, the console generated a iab catheter restriction alarm and the iab was unable to inflate fully.The iab was removed.The customer used a 50cc syringe to test and inflate the iab.More force was applied and a pop sound was heard and the iab was then able to fully inflate.They noticed that certain part of the balloon was still folded and not fully inflated.A new iab was inserted to continue therapy.There was no reported adverse event or injury to the patient.

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10766499
• MDR Text Key: 214763628
• Report Number: 2248146-2020-00572
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000109189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 71