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

Model Number	C304-HIS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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 the implant procedure, the slitter got stuck on the catheter and the physician was unable to complete slitting the catheter.The slitter was removed and replaced with a new, adjustable slitter that was used successfully.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
The patient is a participant in the post approval clinical surveillance product surveillance registry.

• Brand Name: SELECTSITE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8889158
• Report Number: 9612164-2019-03374
• Device Sequence Number: 233624
• Product Code: DQY
• UDI-Device Identifier: 00763000147006
• UDI-Public: 00763000147006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 05/16/2021
• Device Model Number: C304-HIS
• Device Catalogue Number: C304-HIS
• Device Lot Number: 0009745418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 76