• 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 PERFORMER MULLINS 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 PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G09210
Device Problem Kinked (1339)
Patient Problem No Code Available (3191)
Event Date 02/14/2018
Event Type  Injury  
Manufacturer Narrative
Per the initial reporter, the device will not be returned. Pma/510(k) number
=
preamendment. (b)(4). This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during an angioplasty, the 14 fr performer mullins guiding sheath was used to introduce an 8 fr balloon valve and to place a stent; introduction of the balloon occurred without issues. The patient's lesion was located in the pulmonary artery and the course was tortuous. The physician was able to advance the balloon, but was unable to remove the balloon from the sheath after dilation of the artery, and had to remove the entire system from the patient's anatomy. The sheath was observed to have several folds that prevented the angioplasty from being completed. As a result of the sheath folds/ kinking, the physician was required to re-schedule the stent implantation. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information regarding event details and patient anatomy has been requested, but is not available at this time.
 
Manufacturer Narrative
Photographs of the complaint device which were received were also evaluated as part of the investigation of the device. The photo provided by the customer showed that the blue sheath tubing of the device had kinked in several places. The findings of the investigation were not changed.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERFORMER MULLINS 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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7381464
MDR Text Key103818685
Report Number1820334-2018-00775
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002092105
UDI-Public(01)00827002092105(17)200322(10)7770964
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberG09210
Device Catalogue NumberRCFW-14.0-38-75-RB-MTS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2017
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: 03/29/2018 Patient Sequence Number: 1
-
-