MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Inability to Auto-Fill (1044); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A getinge therapy specialist has advised that the iabp was isolated and inspected for blood back, no blood was found in the system internals. Also, no blood back alarms were recorded. Operation of the blood back circuitry was verified by performing a blood back test. No damage was found and the iabp is operational and located in clinical engineering department. No further investigation is required. Device not returned to manufacturer.

Event Description

It was reported that during cs300 intra-aortic balloon pump (iabp) therapy, intra-aortic balloon (iab) rupture occurred; the iab insertion was via axillary approach and fluoroscopy was used during insertion. The iabp catheter ruptured and required removal. The clot was another complication. In addition, the iabp alarmed autofill failure and blood was observed in the helium tube set. The indication for use of the iabp was bridge to heart transplant due to heart failure. We were later advised that the patient developed a clot and required thrombectomy. There was no reported malfunction of the iabp and the customer has not indicated if the patient's injury is attributed to the iabp. Please refer to related mfg report number 2248146-2020-00252 on the involved intra-aortic balloon (iab).

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10148507
• MDR Text Key: 195267665
• Report Number: 2249723-2020-00904
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/12/2020 Patient Sequence Number: 1