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

Model Number	6207-S5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
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 implant procedure, it was noted that patient anatomy had fibrous tissue in the pace pocket, as a result during introducer sheath advance the physician had to apply pressure/force.The introducer sheath ruptured during use, while dilator was in the sheath, and during attempt to place the sheath over the wire.The introducer sheath was removed and replaced with another of the same device.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full introducer was returned and analyzed.Analysis indicated that the sheath of the delivery system was damaged.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: 7254634
• Report Number: 2182208-2018-00101
• Device Sequence Number: 786518
• Product Code: DYB
• UDI-Device Identifier: 10613994391558
• UDI-Public: 10613994391558
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 04/10/2018

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: 07/11/2019
• Device Model Number: 6207-S5
• Device Catalogue Number: 6207-S5
• Device Lot Number: W3817046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 60