Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problems Difficult to Insert (1316); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion on a patient, it was difficult to insert into the sheath and could not advance through.A sheath was used however it is unknown if it was a maquet sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and no visible blood on the catheter.The one-way valve was found to be returned in place.The sheath was not returned for evaluation.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.- an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).Record id (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion on a patient, it was difficult to insert into the sheath and could not advance through.A sheath was used however it is unknown if it was a maquet sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRANS-RAY PLUS 7.5 FR. 35CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8211838
MDR Text Key132051800
Report Number2248146-2019-00005
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/22/2021
Device Catalogue Number0684-00-0604
Device Lot Number3000078924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Device Age YR
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-