MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-XX

Device Problems Flushing Problem (1252); Aspiration Issue (2883)

Patient Problem Death (1802)

Event Date 03/22/2017

Event Type  Death  

Event Description

The customer reported that on (b)(6) 2017 during procedure, difficulty of flush inner lumen after located iab in a patient vessel.Customer replaced syringe to continue therapy, however it was still unable to vacuum blood, and eventually removed catheter.After catheter was removed, the surgeon attempted to inflate it, but iab did not inflate.The surgeon is suspecting that blood back run after removed guide wire.The patient died on (b)(6) 2017.Iabp therapy discontinued.The customer has attributed the patient death to the intra-aortic balloon malfunction and not to a malfunction of the intra-aortic balloon pump.Furthermore, an additional report will be submitted with information regarding the intra-aortic balloon ((b)(4)).

Manufacturer Narrative

(b)(4).The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.The company representative reported that there was no alleged malfunction of the cs100 unit involved in this event, as the unit worked normally and was never taken out of clinical service by the customer.

Event Description

The customer reported that on (b)(6) 2017 during procedure, difficulty of flush inner lumen after located iab in a patient vessel.Customer replaced syringe to continue therapy, however it was still unable to vacuum blood, and eventually removed catheter.After catheter was removed, the surgeon attempted to inflate it, but iab did not inflate.The surgeon is suspecting that blood back run after removed guide wire.The patient died on (b)(6) 2017.Iabp therapy discontinued.The customer has attributed the patient death to the intra-aortic balloon malfunction and not to a malfunction of the intra-aortic balloon pump.Furthermore, an additional report will be submitted with information regarding the intra-aortic balloon (under trackwise #135415/ca-cpl-2017-00813).

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6453615
• MDR Text Key: 71525909
• Report Number: 2249723-2017-00015
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-XX
• Device Catalogue Number: 0998-00-3013-XX
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/19/2017
• Date Device Manufactured: 09/09/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: YAMATO PLUS-R 7.5FR. 30CC IAB - (B)(6)
• Patient Outcome(s): Death
• Patient Age: 80 YR