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

Model Number	6207-D1
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the introducer was returned and analyzed.The mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter was damaged.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the lead introducer wings had broken off too early with resulted in the physician needing scissors to complete the "peal-away" procedure.The introducer was removed.No patient complications have been reported as a result of this event.

• 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: 7389639
• Report Number: 2182208-2018-00349
• Device Sequence Number: 69561
• Product Code: DYB
• UDI-Device Identifier: 00681490142977
• UDI-Public: 00681490142977
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/02/2018

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: 05/11/2019
• Device Model Number: 6207-D1
• Device Catalogue Number: 6207-D1
• Device Lot Number: W3748963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1