MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Injury (2348)

Event Date 10/05/2020

Event Type  Death  

Manufacturer Narrative

Event site postal code: (b)(6).The device was not returned, and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.There is currently a field action# res 85823 in process that is related to this event.Complaint #: (b)(4).

Event Description

An aortic valve replacement associated with pericardial patch (re-operation) was performed.A datascope trans ray plus 35cc intra-aortic balloon (iab) catheter was used along with an unknown datascope intra-aortic balloon pump (iabp) to provide iabp counterpulsation therapy as well.The surgery was completed successfully and iabp therapy was continued after the surgery.Three days later, the iabp therapy was discontinued and the iab catheter was removed safely from the patient.The iab catheter was discarded in the hospital.It was reported that after removal of the of the iab catheter, the patient condition deteriorated and a positive reaction was observed for endotoxin shock the following morning.There was no reported malfunction of the datascope intra-aortic balloon.A separate report has been sent for the iabp under mfg report number 2249723-2020-01771.

Manufacturer Narrative

Additional information outcome attributed to ae, date of death, type of reportable event, patient codes.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint # (b)(4).

Event Description

An aortic valve replacement associated with pericardial patch (re-operation) was performed.A datascope trans ray plus 35cc intra-aortic balloon (iab) catheter was used along with an unknown datascope intra-aortic balloon pump (iabp) to provide iabp counterpulsation therapy as well.The surgery was completed successfully and iabp therapy was continued after the surgery.Three days later, the iabp therapy was discontinued and the iab catheter was removed safely from the patient.The iab catheter was discarded in the hospital.It was reported that after removal of the of the iab catheter, the patient condition deteriorated and a positive reaction was observed for endotoxin shock the following morning.The patient expired on (b)(6) 2020.There was no reported malfunction of the datascope intra-aortic balloon.A separate report has been sent for the iabp under mfg report number 2249723-2020-01771.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC 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: 10766106
• MDR Text Key: 216115838
• Report Number: 2248146-2020-00567
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000109191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 68 YR
• Patient Weight: 50