MAUDE Adverse Event Report: MEDTRONIC, INC SHERPA ACTIVE 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	SA6IMAK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Atrial Perforation (2511)
Date of Event	02/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During index renal denervation procedure the left renal artery was treated first.Six ablations were performed.Right renal artery was treated second.Four ablations were performed.It was reported that there was an arterial puncture with use of the catheter during the index procedure.The puncture could be seen only after the procedure.Two days later the patient experienced a minor hematoma of the right groin.No treatment was given.Investigator indicated that the reported hematoma event is definitely related to the renal denervation device and procedure.It was confirmed that the hematoma was the result of an unintended arterial puncture/perforation.Location of the punctured vessel was in the groin.No treatment was provided.The hematoma resolved spontaneously.

• Brand Name: SHERPA ACTIVE 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7094850
• Report Number: 1220452-2017-00127
• Device Sequence Number: 19301355
• Product Code: DQY
• UDI-Device Identifier: 00613994824059
• UDI-Public: 00613994824059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042489
• 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): 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2017
• Device Catalogue Number: SA6IMAK
• Device Lot Number: 0007602230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Weight: 85