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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL PTFE PEELABLE INTRODUCER KIT, 6FR; INTRODUCER, CATHETER
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GREATBATCH MEDICAL PTFE PEELABLE INTRODUCER KIT, 6FR; INTRODUCER, CATHETER Back to Search Results
Model Number 1000558-001
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/02/2016
Type of Reportable Event Malfunction
Event or Problem Description
Information was received that during the implant procedure, the cephalic vein puncture was performed.When removing this introducer, a breakage occurred; the introducer did not peel apart appropriately.The physician used tweezers to remove the broken introducer.The procedure was completed with no further complications.
 
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Brand Name
PTFE PEELABLE INTRODUCER KIT, 6FR
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
GREATBATCH MEDICAL
2300 berkshire lane n
minneapolis MN 55441
MDR Report Key5460516
Report Number2183787-2016-00013
Device Sequence Number725601
Product Code DYB
UDI-Device Identifier00802526527807
UDI-Public(01)00802526527807(17)170820(10)W3183152
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K102540
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 02/12/2016
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
Operator of Device Health Professional
Device Expiration Date08/20/2017
Device Model Number1000558-001
Device Catalogue NumberBSC7087
Device Lot NumberW3183152
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2016
Initial Report FDA Received Date02/25/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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