MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN 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 04/01/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Device not returned.

Event Description

Please refer to mfg report number 2248146-2020-00157 for the related intra-aortic balloon catheter. Last april, the (b)(6) received news of an unfortunate event regarding the death of a (b)(6) yo male patient. The patient was being treated for coronary artery stenting following an mi. Shortly into the procedure, following contrast media infusion, guidewire placement and balloon catheter angioplasty, he complained of being unwell (and a ¿burning sensation¿ in his head?) and rapidly deteriorated on the table and suffered heart failure. It is suggested by the treating cardiologist that the patient experienced a sudden deterioration related to possible anaphylaxis and that this could be have been induced by polyethylene glycol (peg) exposure. The patient had a prior diagnosis of allergy to peg. It is not clear whether the patient suffered a fatal cardiac arrest due to their existing cardiac disorder and treatment, or whether this deterioration was indeed anaphylaxis and directly/indirectly brought on by exposure to peg. The pathologist has not ruled out this possibility. Recently, hm coroner has provided medical records to properly interested persons including (b)(6), and in those medical records is a page on ¿equipment barcodes¿ and details of devices used to treat the patient. One device is listed to be a sensation plus 8 fr, 50cc iab catheter manufactured by getinge.

• Brand Name: UNKNOWN
• 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: 9888846
• MDR Text Key: 185247673
• Report Number: 2249723-2020-00510
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/02/2020
• 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 Treatment Data

Date Received: 03/27/2020 Patient Sequence Number: 1

Treatment

SENSATION PLUS 8 FR 50CC IAB