MAUDE Adverse Event Report: MEDTRONIC, INC. PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI); INTRODUCER, CATHETER

Model Number	6209-S1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
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 the introducer became damaged during the implant procedure.The damage was described as being "loose" or "detached".No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis summary: the introducer was returned without the dilator, and analyzed.Analysis indicated that the mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 8401900
• Report Number: 2182208-2019-00468
• Device Sequence Number: 13516210
• Product Code: DYB
• UDI-Device Identifier: 00681490143349
• UDI-Public: 00681490143349
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K911236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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 Date: 08/13/2020
• Device Model Number: 6209-S1
• Device Catalogue Number: 6209-S1
• Device Lot Number: W4453032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1