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

Model Number	6209-S1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.Analysis indicated there was a mechanical issue with the dilator of the lead introducer.The sheath of the lead introducer was torn.The sheath of the lead introducer was kinked/buckled.Visual analysis of the introducer indicated damage during use.The analyst noted the introducer returned with the dilator still inserted in it.Visual inspection found the dilator tip melted and its distal end bent.The dilator tip found melted, and this stated in the reported of ¿plastic that had been exposed to heat for too long and becomes stiff¿.The introducer sheath was tear due to kinked/buckled near to the wings.These finding indicated force was applied during use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the rigidity/stiffness of the introducer was noted on the tip of the dilator.The introducer was not required. 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
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13058426
• Report Number: 2182208-2021-05036
• Device Sequence Number: 11750023
• Product Code: DYB
• UDI-Device Identifier: 00643169646179
• UDI-Public: 00643169646179
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 01/29/2023
• Device Model Number: 6209-S1
• Device Catalogue Number: 6209-S1
• Device Lot Number: GB6263280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown