MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Break (1069); Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Date 05/03/2018

Event Type  Death  

Manufacturer Narrative

The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy with a fiber optic catheter that the patient went into full code with loss of the optical sensor and electrocardiogram (ecg) signal. An optical sensor failure alarm was generated. There could have been a possible fiber optic break in the catheter due to cpr(cardiopulmonary resuscitation). There was an attempt to establish blood pressure signal via central lumen, but the customer was having trouble finding the cable. An ecg signal was present, but poor. The emergency service specialist informed the customer to switch to a semi-auto mode and attempt to find a lead that could be seen. There was a weak signal established in avr(augmented vector right) but not strong enough for pump to pick-up r waves. Finally the customer was able to get the cable and hooked up to the transducer. The patient proceeded to code again. After zeroing, the customer was able to get a pressure signal from cpr effort and pump began working. The emergency service specialist verified that the customer had cables on each pump for pressure transducer. The patient expired due to underlying disease, but the death was not attributed to the device by the facility. The date of death is unknown.

• Brand Name: SENSATION UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7554415
• MDR Text Key: 109615635
• Report Number: 2248146-2018-00364
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/30/2018 Patient Sequence Number: 1