MAUDE Adverse Event Report: MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER

Model Number	6207-S1
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.Analysis indicated the sheath of the lead introducer was kinked/buckled.The sheath of the lead introducer was torn.Visual analysis of the introducer indicated damage during use.The analyst noted the introducer was received with the dilator still inserted.The sheath was received kinked at 11 cm and torn at 13 cm from the wing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the introducer was attempted/not used and replaced during an implant procedure.The introducer was returned to the manufacturer and subsequently tested out-of-specification during the manufacturer's analysis.No patient complications have been reported as a result of this event.

• 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 Key: 12510538
• Report Number: 2182208-2021-03733
• Device Sequence Number: 4094653
• Product Code: DYB
• UDI-Device Identifier: 00681490143011
• UDI-Public: 00681490143011
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K911236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 08/04/2022
• Device Model Number: 6207-S1
• Device Catalogue Number: 6207-S1
• Device Lot Number: W5935028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR