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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab.There was no further information provided.(b)(6).Additional information has been requested, and a supplemental report will be sent upon receipt.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured.The nurse called the physician and the advanced licensed practitioner assessed the event to report blood marching up the catheter towards the pump.The intra-aortic balloon pump (iabp) then stopped inflating.Furthermore, the catheter was discontinued.The patient received platelets due to platelet count being 48; therefore, this was done to help prevent bleeding due to the discontinuation of the catheter.The iab was discarded, and per physicians notes, "the patient remained stable." there was no report of patient death in relation to this reported event.There as no report of this event being attributed to the intra-aortic balloon pump.A complaint was opened on (b)(4) to report the involved balloon catheter in this event.

Manufacturer Narrative

The customer did not request getinge service in connection with this event.However, the customer advised us that the issue was the balloon catheter and not the iabp, thus there was no need for evaluation and/or repair of the involved unit.In addition, the customer reiterated that the information on the pump model and serial number is unavailable.

Event Description

Per facility medwatch, it was reported that during intra-aortic balloon pump (iabp) therapy, the intra-aortic balloon catheter (iabc) ruptured.The nurse called the physician and the advanced licensed practitioner to assess the situation and blood was observed marching up the catheter towards the iabp.The iabp then stopped inflating and the iabc was removed from the patient.The patient received platelets due to platelet count being 48; therefore, this was done to help prevent bleeding due to the removal of the catheter and discontinuation of therapy.The iabc was discarded, and per physicians notes, "the patient remained stable." the exact iabp model/type was not reported to us.A separate report on the involved iabc was submitted under report #2248146-2018-00162.

• Brand Name: UNKNOWN
• 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: 7327545
• MDR Text Key: 102016903
• Report Number: 2249723-2018-00380
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: UKNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 03/16/2018
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 93