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

Model Number N/A

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

Patient Problems Stroke/CVA (1770); Cardiogenic Shock (2262); Injury (2348)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The pump model and serial number of the involved iabp has not been reported to us.Additionally, there was no reported malfunction of the involved iabp; however, additional information has been requested, and if received, we will submit a supplemental report.Returned to manufacturer.

Event Description

It was reported that during use on a patient it was reported that after approximately two days of an unknown intra-aortic balloon pump (iabp) therapy, the intra-aortic balloon catheter (iabc) ruptured.The insertion was reported to be axillary, which is off-label use.The patient reportedly experienced a cerebrovascular accident (cva) and went into cardiogenic shock.There was no reported malfunction of the iabp involved in the event.The patient was subsequently placed on hospice care.From medwatch mfg report number mw5094864: there was a reported injury to the patient.Patient was taken to interventional radiology for potential thrombectomy; however, this was limited by lack of flow.Hemorrhagic conversion of the cva and patient went into cardiogenic shock.Patient was the discharged from the facility to hospice.Please refer to mfg report number 2248146-2020-00305 for information on the involved iabc.

• Brand Name: UNKNOWN IABP
• 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: 10477819
• MDR Text Key: 205160133
• Report Number: 2249723-2020-01396
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 40CC
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 60