MAUDE Adverse Event Report: MEDTRONIC, INC. SOLO-TRAK PERCUTANEOUS LEAD INTRODUCER (PLI) KITS; INTRODUCER, CATHETER

Model Number	6207BTK-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
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 the implant procedure, the product was already damaged upon opening the package.The tip of the syringe, which was included in the device packaging "had already been out of the straight" and the syringe became unusable due to air ingress from the damage part of the tip when performing puncture.A different syringe was used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the tip of the syringe was damaged.The noted damage was the tip was partially separated from the body of the syringe.Despite noted syringe damage, an attempt to use was made.

• Brand Name: SOLO-TRAK PERCUTANEOUS LEAD INTRODUCER (PLI) KITS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7891446
• Report Number: 2182208-2018-01718
• Device Sequence Number: 1939884
• 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,Followup
• Report Date (Section B): 09/27/2018

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: 12/13/2019
• Device Model Number: 6207BTK-1
• Device Catalogue Number: 6207BTK-1
• Device Lot Number: W4073135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR