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

Model Number N/A

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

Patient Problem Death (1802)

Event Date 01/11/2021

Event Type  Death  

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.There was no repair performed on the unit.A supplemental report will be submitted if additional information is provided.Patient height: 63".

Event Description

It was reported that during use the iab (intra-aortic balloon) inflated prior to insertion.The iabp (intra-aortic balloon pump) reported to be used was a cardiosave.It was reported that later the patient expired.Additionally, the facility reported that the iabp in use did not contribute to the patient death.Iabp inserted on 1/1/21 in ccl under fluoroscopy iabp was removed on 1/5 after 1:2 and 1:3 and patient hemodynamically stable.The iabs in use are reported on separate mdrs.Reference # 2248146-2021-00059 and # 2248146-2021-00060.

Manufacturer Narrative

Analysis of production: (3331/3221) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/3221) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (41103221) the overall 24 month product complaint trend data for the period (feb 2020 through jan 2021) was reviewed.There were no triggers identified for the review period.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP (IABP)
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11282598
• MDR Text Key: 230426311
• Report Number: 2249723-2021-00211
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 34CC; SENSATION PLUS 34CC.
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 62