MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS

Model Number	C304L6906
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
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 sheath broke when it was used to deliver the sheath.It was difficult to reach the required position.A different sheath was used to complete the operation.No patient complications have been reported as a result of this event.

• Brand Name: SELECTSITE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8025308
• Report Number: 9612164-2018-03007
• Device Sequence Number: 13847596
• Product Code: DQY
• UDI-Device Identifier: 00613994729774
• UDI-Public: 00613994729774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 08/11/2018
• Device Model Number: C304L6906
• Device Catalogue Number: C304L6906
• Device Lot Number: 0008156189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR