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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR INTRODUCER SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G09908
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Customer name and address
=
phone: (b)(6). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
Reportedly, during a percutaneous transluminal angioplasty, the radiopaque band was not visible on a flexor introducer sheath. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameFLEXOR INTRODUCER 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 Key12011848
MDR Text Key256725527
Report Number1820334-2021-01519
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002099081
UDI-Public(01)00827002099081(17)240331(10)13861362
Combination Product (y/n)N
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG09908
Device Catalogue NumberKCFW-6.0-35-45-RB
Device Lot Number13861362
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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