• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC GUIDELINER CATHETER

  • 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
 

VASCULAR SOLUTIONS, INC GUIDELINER CATHETER Back to Search Results
Model Number 5571
Device Problem Device Damaged by Another Device (2915)
Patient Problem Death (1802)
Event Date 07/13/2017
Event Type  Death  
Manufacturer Narrative

A manufacturing record review was completed and zero nonconformances were found. The returned product evaluation determined that the collar of the catheter had damage consistent with a stent being pushed into it. This happened during the use of the catheter. The event description states that strong resistance was encountered at the transition of the rx lumen. Without receiving the concomitant device for analysis the root cause of the stent not passing through the rx lumen is undeterminable. Attempts were made to obtain patient information, cause including date of death, however, unable to capture this information. (reported that the cause of death is unknown, but it is not due to cardiac event) asku actual date of death.

 
Event Description

Unable to insert a stent. The patient was in cardiac arrest due to ami, and carried into the operation room while receiving the cardiac massage. Pci was performed with percutaneous cardiopulmonary support (pcps) and intra aortic balloon pumping (iabp). The lesion was #5-6, and pre-dilation of lesion was performed, then a stent (3. 5 mm) was inserted, but it did not pass the lesion. Guideliner was then inserted into the body, and the same stent was inserted; however, the stent got stuck at the transition of half-pipe and rx lumen, and a strong resistance was encountered. A different feeling was felt during guideliner manipulation. A strong resistance was also felt when the stent got stuck at the collar of guideliner. The guideliner was removed and a different catheter was used instead. The same stent could be passed through this catheter and implanted without problems, and the operation was completed. The patient went back to the hospital ward, but passed away later (the cause of death is unknown, but it is not due to cardiac event. ).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUIDELINER
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564230
MDR Report Key6791758
MDR Text Key82607566
Report Number2134812-2017-00063
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK112082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 07/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/09/2018
Device MODEL Number5571
Device LOT Number604342
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/14/2017 Patient Sequence Number: 1
-
-