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

Model Number	SB6IMAK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/12/2020
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
Patient is in control group, on med.During the control procedure one sherpa guide catheter was used.Approximately 7 months later there was suspicion of dissection of the left renal artery.No action taken.The investigator assessed the event as possibly related to the procedure and not related to the therapy, study catheter or the study generator.Site commented "possible relation to renal angiogram and dissection unlikely but cannot be excluded".Patient recovered without sequelae.

• Brand Name: SHERPA BALANCED 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10132080
• Report Number: 1220452-2020-00047
• Device Sequence Number: 19796634
• Product Code: DQY
• UDI-Device Identifier: 00613994827272
• UDI-Public: 00613994827272
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132673
• 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): 06/09/2020

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: 05/28/2021
• Device Model Number: SB6IMAK
• Device Catalogue Number: SB6IMAK
• Device Lot Number: 0009761698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/09/2020
• 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: 62 YR
• Patient Weight: 135