MAUDE Adverse Event Report: DATASCOPE MAHWAH SYSTEM 98; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Alarm System (1012); Difficult to Remove (1528); Contamination /Decontamination Problem (2895)

Patient Problems Death (1802); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)

Event Date 10/30/2018

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A company representative has reported that the customer has not alleged a malfunction of the involved iabp and that the iabp remains in clinical use at the event site.(b)(6).

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy, the intra-aortic balloon catheter (iabc) was placed smoothly on a patient and two days later, brown spots were observed in the inflatable tube.The customer stated that the iabp did not alarm and on the morning of (b)(6) 2018, the iabp alarmed "autofill failure" & "check iab catheter" and more blood was observed.The customer attempted to remove the catheter, but it could not be removed.From 9 a.M.To 3 p.M.All interventional procedures in the cath lab were not available, and abdominal aortography was shown in the abdomen.The aorta was obstructed and the patient died at 3 p.M after ventricular fibrillation.The iabc was still not removed from the patient, and it was cut off to leave part of the external extension tube.The customer has not attributed the patient's death to the iabp, and has not alleged malfunction of the iabp.Please refer to medwatch # 2248146-2018-00671 for details on the involved balloon catheter.

• Brand Name: SYSTEM 98
• 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: 8095313
• MDR Text Key: 128113677
• Report Number: 2249723-2018-02024
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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: 0998-00-0446-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2004
• 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: 64 YR
• Patient Weight: 68