MAUDE Adverse Event Report: DATASCOPE MAHWAH SYS98XT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Folded (2630)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 01/30/2018

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed as soon as the dhr is made available, and a supplemental report will be provided if necessary.The company representative from the business unit has advised that the customer has not alleged a malfunction of the iabp, and that the iabp remains in clinical use.

Event Description

It was reported that during sys98xt intra-aortic balloon pump (iabp) therapy, upon opening the balloon package, a fold was found on the catheter.The customer indicated that something may have been wrong with the catheter and opened another package and iabp therapy was initiated.The indication for use was acute myocardial infarction (ami).Subsequently, the patient died on (b)(6) 2018 as a result of heart disease after iabp therapy.The customer has confirmed that the patient's death is not attributed in any way with the iabp.Separate reports will be submitted on the two balloon catheters under complaints (b)(4).

• Brand Name: SYS98XT
• 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: 7293185
• MDR Text Key: 100842494
• Report Number: 2249723-2018-00300
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• 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: 0998-00-0479-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/31/2018
• Date Device Manufactured: 05/01/1997
• 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
• Patient Outcome(s): Death
• Patient Age: 45 YR
• Patient Weight: 60