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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operating procedure since the serial number for the unit was not provided.Additional information has been requested, and we will report accordingly when it becomes available.The full event site name is (b)(6) university (b)(6) hospital.Not returned to manufacturer.

Event Description

It was reported that after two days of intra-aortic balloon (iab) therapy, bleeding was observed around the hemostasis valve of the competitor¿s sheath.The doctor confirmed the balloon was pulled towards the front.When the device was checked visually, the connection between the universal sheath seal of the reported balloon catheter and the hemostasis valve of the competitor¿s sheath was loose.When the balloon was re-inserted into the hemostasis valve of the sheath and the connection between both the devices were secured, bleeding stopped.The patient had been in stable condition although the hemorrhage volume was noted to be 500cc.Intra-aortic balloon pump (iabp) therapy was completed.

Manufacturer Narrative

Updated fields: b4, b5, g4, g7, h2, h6, h10.A company representative has advised that the information for the involved iabp is unavailable, and that the customer has neither alleged anomalies or malfunction of the iabp and the iabp did not require repair for this event.No further investigation is required.

Event Description

It was reported that after two days of intra-aortic balloon(iab) therapy, bleeding was observed around the hemostasis valve of the competitor¿s sheath.The doctor confirmed the balloon was pulled towards the front.When the device was checked visually, the connection between the universal sheath seal of the reported balloon catheter and the hemostasis valve of the competitor¿s sheath was loose.When the balloon was re-inserted into the hemostasis valve of the sheath and the connection between both the devices were secured, bleeding stopped.The patient had been in stable condition although the hemorrhage volume was noted to be 500cc.Intra-aortic balloon pump(iabp) therapy was completed.Please refer to mfg report number (b)(4) for information on the intra-aortic balloon (iab).

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9483703
• MDR Text Key: 184532722
• Report Number: 2249723-2019-02057
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANS-RAY 7FR. 34CC.; TRANS-RAY 7FR. 34CC.
• Patient Outcome(s): Other