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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL COOLEY DILATOR 6/SET
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TELEFLEX MEDICAL COOLEY DILATOR 6/SET Back to Search Results
Catalog Number 355315
Device Problem Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was the reported that the device was rough and sticking to the vessel and they soaked the dilators with heparin/saline solution.After completing surgery, the doctor inspected the saved vessel and noticed that there was a tear inside the vessel.The doctor inspected the dilators and noticed that on size 2 had a grainy, sand like texture and the dilators are supposed to be smooth.There was no patient injury.
 
Manufacturer Narrative
(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 355315.(2) sets of dilators were received for evaluation.1 of 2 are still sealed in the original package.The open (used) set was reviewed against the product drawing.The product drawing defines the finish of these devices as "matte" which is consistent with the samples provided.Only garrett, hiebert and debakey dilators are smooth.Device conforms to product specifications for finish and according to specification.A credit should be issued to the customer.We will continue to monitor and trend these complaints.
 
Event Description
It was the reported that the device was rough and sticking to the vessel and they soaked the dilators with heparin/saline solution.After completing surgery, the doctor inspected the saved vessel and noticed that there was a tear inside the vessel.The doctor inspected the dilators and noticed that on size 2 had a grainy, sand like texture and the dilators are supposed to be smooth.There was no patient injury.
 
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Brand Name
COOLEY DILATOR 6/SET
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7578492
MDR Text Key110584681
Report Number3011137372-2018-00141
Device Sequence Number1
Product Code DWP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/10/2018
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? Yes
Device Operator Health Professional
Device Catalogue Number355315
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2018
Initial Date FDA Received06/07/2018
Supplement Dates Manufacturer Received06/26/2018
Supplement Dates FDA Received07/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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