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

Catalog Number 0684-00-0567

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Urinary Retention (2119)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

The customer indicated that the product will not be returning to the manufacturer and we're unable to complete an evaluation on the affected product.If additional information becomes available a supplemental report with our additional findings will be sent.Complaint # (b)(4).

Event Description

A sensation plus 40cc balloon was used on a patient and the following day the patients' urine output declined.They checked the iab placement and it migrated down 3 cm.The doctor advanced it and almost immediately migrated it back down; the iab was removed and the patients' vitals remained stable and urine output returned.

Manufacturer Narrative

Date received by manufacturer: 08/17/2016.

Event Description

A sensation plus 40cc balloon was used on a patient and the following day the patients' urine output declined.They checked the iab placement and it migrated down 3 cm.The doctor advanced it and almost immediately migrated it back down; the iab was removed and the patients' vitals remained stable and urine output returned.

• 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
• MDR Report Key: 5947376
• MDR Text Key: 54626792
• Report Number: 2248146-2016-00076
• 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,consum
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,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: Health Professional
• Device Catalogue Number: 0684-00-0567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: 08/17/2016
• Supplement Dates FDA Received: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention