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

Model Number	6207-S5
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
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 a lead implant procedure, when the initial splitting of the introducer the hub separated from the sheath body during the peel the physician encountered difficulty to part the introducer with scissors to remove from the lead body during a pacemaker implant.This added considerable time to the implant.The introducer sheath was found to have difficulty with the peeling.The hub was cracked and the sheath would not split along the score line length wise.The introducer was removed and replaced with a different introducer.The second introducer encountered the same issue.The procedure was subsequently completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed, and the mechanical operation of the catheter shaft peeling was not following score line.If information is provided in the future, a supplemental report will be issued.
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 a lead implant procedure, when the initial splitting of the introducer the hub separated from the sheath body during the peel the physician encountered difficulty to part the introducer with scissors to remove from the lead body during a pacemaker implant.This added considerable time to the implant.The introducer sheath was found to have difficulty with the peeling.The hub was cracked and the sheath would not split along the score line length wise.The introducer was removed and replaced with a different introducer.The second introducer encountered the same issue.The procedure was subsequently completed.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: 7413797
• Report Number: 2182208-2018-00391
• Device Sequence Number: 11002708
• Product Code: DYB
• UDI-Device Identifier: 10613994391558
• UDI-Public: 10613994391558
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 05/23/2018

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: 10/03/2019
• Device Model Number: 6207-S5
• Device Catalogue Number: 6207-S5
• Device Lot Number: W3951717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 05/21/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/18/2018; 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1