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

Model Number	6207BTK-1
Medical Device Problem Codes	Accessory Incompatible (1004); Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
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 an implant procedure the guidewire did not go through the puncture needle of the introducer.It was noted there was presumably an anomaly of the joint of the needle and the plastic.It was also reported there was a loose/ detached part.The introducer was removed and another product was used to complete the procedure.No patient complications have been reported as a result of this event.

• Brand Name: SOLOTRAK KR 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: 8950098
• Report Number: 2182208-2019-01587
• Device Sequence Number: 2399805
• Product Code: DYB
• UDI-Device Identifier: 00681490142939
• UDI-Public: 00681490142939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/30/2019

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: 01/22/2021
• Device Model Number: 6207BTK-1
• Device Catalogue Number: 6207BTK-1
• Device Lot Number: W4681493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1