MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problems Device Alarm System (1012); Entrapment of Device (1212); Device Displays Incorrect Message (2591)

Patient Problem Granuloma (1876)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product is promised for return but has not yet been received.As a result, we are unable to complete an evaluation.We continue our good faith efforts for the return of the product.A supplemental report will be provided if new information becomes available.(b)(4).

Event Description

It was reported that the alarm sounded twice to check iab catheter and blood seen in extension tubing but facility continue to pump for 36 hours and blood detected alarm went off and blood was detected in the extension tubing.Patient taken to the or to get the catheter removed as it was entrapped with granulation and is currently reported to be stable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the alarm sounded twice to check iab catheter and blood seen in extension tubing but facility continue to pump for 36 hours and blood detected alarm went off and blood was detected in the extension tubing.Patient taken to the o.R.To get the catheter removed as it was entrapped with granulation and is currently reported to be stable.

Manufacturer Narrative

(b)(4).The iab catheter was returned completely separated in three parts with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extension tubing was also returned.A portion of the extracorporeal tubing was without the male luer.A large tear was observed on the membrane near the proximal end approximately 5.6cm from the rear seal.An underwater leak test of sections of the balloon, catheter and y-fitting was performed and no additional leaks were detected besides the large tear on the membrane.The tear found on the membrane appears to have been caused by a sharp object.This may have occurred during iab removal from the patient.We were unable to test the complete iab catheter for the reported problem due to parts of the device not returned and its returned condition.(b)(4).Supplement - device evaluation.

Event Description

It was reported that the alarm sounded twice to check iab catheter and blood seen in extension tubing but facility continue to pump for 36 hours and blood detected alarm went off and blood was detected in the extension tubing.Patient taken to the or to get the catheter removed as it was entrapped with granulation and is currently reported to be stable.

Manufacturer Narrative

Initial date received by manufacturer for this event was 12/06/2016.This information was inadvertently not included in the initial mdr.(b)(4).Supplement - included returned to manufacturer date - (additional information).

Event Description

It was reported that the alarm sounded twice to check iab catheter and blood seen in extension tubing but facility continue to pump for 36 hours and blood detected alarm went off and blood was detected in the extension tubing.Patient taken to the or to get the catheter removed as it was entrapped with granulation and is currently reported to be stable.

Manufacturer Narrative

Correction: date was inadvertently not entered in the follow up mdr #3.Manufacturer date: 02/06/2017.

Event Description

It was reported that the alarm sounded twice to check iab catheter and blood seen in extension tubing but facility continue to pump for 36 hours and blood detected alarm went off and blood was detected in the extension tubing.Patient taken to the or to get the catheter removed as it was entrapped with granulation and is currently reported to be stable.

• Brand Name: SENSATION PLUS 7.5FR. 40CC 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: 6215618
• MDR Text Key: 63639619
• Report Number: 2248146-2016-00099
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2018

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0684-00-0567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 02/06/2017
• Supplement Dates FDA Received: 02/01/2017; 02/03/2017; 02/07/2017; 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 32