• 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 INTRODUCER 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 INTRODUCER SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-7.0-38-45-RB
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
 
Event Description
It was reported that during a procedure, the flexor introducer sheath valve disconnected and the patient experienced significant blood loss.Additional information regarding the valve separation, patient's anatomy and outcome, and quantification of blood loss has been requested, but is not available at this time.
 
Manufacturer Narrative
Additional information: attempts were made for additional information regarding the valve separation, patient's anatomy, outcome, and quantification of blood loss; however this information was unable to be provided.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control, was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record noted two nonconforming events that were not related to the reported failure mode.All non-conforming product were scrapped or re-worked as appropriate.It should also be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLEXOR INTRODUCER SHEATH
Type of Device
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7023064
MDR Text Key91803909
Report Number1820334-2017-03675
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002098107
UDI-Public(01)00827002098107(17)200519(10)7927432
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberKCFW-7.0-38-45-RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/19/2017
Initial Date FDA Received11/10/2017
Supplement Dates Manufacturer Received01/30/2018
Supplement Dates FDA Received02/05/2018
Date Device Manufactured05/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-