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

Catalog Number 0684-00-0474

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Event site zip code: (b)(4).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 Description

It was reported that just after the insertion of an intra-aortic balloon catheter (iab), the console generated a check iab catheter alarm.The customer checked the tubing and connections, but found no visible kink or leak in the circuit.Iab therapy was continued with a new iab catheter.There was no reported injury to the patient.

Event Description

It was reported that just after the insertion of an intra-aortic balloon catheter (iab), the console generated a check iab catheter alarm.The customer checked the tubing and connections, but found no visible kink or leak in the circuit.Iab therapy was continued with a new iab catheter.There was no reported injury to the patient.

Manufacturer Narrative

Additional information sex - female.Age at time of event - 67.Age units (patient) - years.Weight - 67.Weight (units) - kgs.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).

Manufacturer Narrative

Additional information section h - evaluation method codes added: historical data analysis; 4109.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.Reference complaint #(b)(4).

Event Description

It was reported that just after the insertion of an intra-aortic balloon catheter (iab), the console generated a check iab catheter alarm.The customer checked the tubing and connections, but found no visible kink or leak in the circuit.Iab therapy was continued with a new iab catheter.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with no visible blood on the exterior of the catheter.No physical damage noted.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.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.The device meets all product specifications.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 just after the insertion of an intra-aortic balloon catheter (iab), the console generated a check iab catheter alarm.The customer checked the tubing and connections, but found no visible kink or leak in the circuit.Iab therapy was continued with a new iab catheter.There was no reported injury to the patient.

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.Reference complaint #(b)(4).

Event Description

It was reported that just after the insertion of an intra-aortic balloon catheter (iab), the console generated a check iab catheter alarm.The customer checked the tubing and connections, but found no visible kink or leak in the circuit.Iab therapy was continued with a new iab catheter.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 34CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9841258
• MDR Text Key: 185923665
• Report Number: 2248146-2020-00151
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000058903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 67