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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER
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MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER Back to Search Results
Model Number 6207-S5
Date of Event 09/23/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.The introducer did not peel along the score lines.Visual analysis of the introducer indicated damage during use.The analyst noted the introducer was returned without the dilator.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during an implant procedure for a pacing lead, the handle of the introducer snapped off.The sheath had to be cut away rather than splitting.No patient complications have been reported as a result of this event.
 
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Brand Name
PERCUTANEOUS LEAD INTRODUCER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key10747329
Report Number2182208-2020-02545
Device Sequence Number1926570
Product Code DYB
UDI-Device Identifier00613994391551
UDI-Public00613994391551
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 10/28/2020
1 Device 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 Date05/06/2022
Device Model Number6207-S5
Device Catalogue Number6207-S5
Device Lot NumberW5833606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2020
Initial Report FDA Received Date10/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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