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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Difficult to Insert (1316); Defective Component (2292); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2019
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. Complaint record id # (b)(4). Device not returned.
 
Event Description
The intra-aortic balloon catheter (iabc) was used for percutaneous coronary intervention (pci) backup. It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was unable to be advanced into the balloon. The iab was replaced to continue therapy. There was no reported injury to the patient.
 
Event Description
The intra-aortic balloon catheter (iabc) was used for percutaneous coronary intervention (pci) backup. It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was unable to be advanced into the balloon. The iab was replaced to continue therapy. There was no reported injury to the patient.
 
Manufacturer Narrative
The iab catheter was returned with the membrane folded inside the t-handle and the guide wire partially inside the iab lumen. No blood was visible on the catheter. The sheath and dilator was also returned. No damage was observed on the iab or returned components. The technician was able to remove the guide wire from the iab lumen without difficulty. The technician attempted to insert the returned 0. 025¿ guide wire through the inner lumen and was able to successfully insert the guide wire. No obstructions were felt. The reported events cannot be confirmed by the evaluation. 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. Complaint # (b)(4).
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8798146
MDR Text Key151312501
Report Number2248146-2019-00601
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 12/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2022
Device Catalogue Number0684-00-0605
Device Lot Number3000091324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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