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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI); INTRODUCER, CATHETER
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MEDTRONIC, INC. PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI); INTRODUCER, CATHETER Back to Search Results
Model Number 6207-S5
Medical Device Problem Code Accessory Incompatible (1004)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during use the introducer would not accept lead, and was removed and found to have kinked and/or split within vein.A different introducer was used to complete the procedure.No patient complications have been reported as a result of this event.
 
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Brand Name
PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI)
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key8238088
Report Number2182208-2019-00076
Device Sequence Number1593800
Product Code DYB
UDI-Device Identifier00613994391551
UDI-Public00613994391551
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K911236
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/10/2019
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 Date07/11/2020
Device Model Number6207-S5
Device Catalogue Number6207-S5
Device Lot NumberW4392133
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date01/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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