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

MAUDE Adverse Event Report: COOK INC FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, 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
 

COOK INC FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-8.0-38-70-RB-RAABE
Device Problems Break (1069); Unraveled Material (1664)
Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Intra-Abdominal Hemorrhage (4479)
Event Date 12/08/2021
Event Type  Death  
Manufacturer Narrative
Initial reporter: occupation
=
administration officer. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during an angiogram of the right lower extremity with possible intervention, a flexor raabe guiding sheath separated in the patient. The device was retrieved with a snare and the patient was transferred to another hospital. The patient was considered high risk, with many pre-existing conditions. During the same procedure, a cook advance 35 lp low profile balloon catheter also separated. That event will be reported under patient identifier (b)(6). According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXOR RAABE GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13118191
MDR Text Key282970186
Report Number1820334-2021-02754
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKCFW-8.0-38-70-RB-RAABE
Device Lot Number9417934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/31/2022
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 Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
PTA5-35-135-5-4.0 OR PTA5-35-135-6-10.0
-
-