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

Catalog Number	SA6RDND1K
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
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
A sa6rdnd1k sherpa catheter was intended to be used during a renal denervation procedure.The sherpa catheter was used for both left and right renal artery.No damage noted to packaging.Device was removed from packaging as per ifu.The device was inspected with no issues and prepped with no issues as per ifu.There were no issues noted when inserting the sherpa device.A 6f non-mdt introducer was used.A non-mdt guidewire and a symplicity spyral rdn catheter was also used.It is reported that device damage occurred.The outer layer separated from the inner layer at the end of the procedure when the device was exiting the introducer.The outside of the guide catheter was not wiped at any stage and the device was not re-sterilized.Aspiration was not performed in the procedure.It is indicated that there are no device fragments remaining in the patient, all the pieces seemed to be within the introducer.It is stated that the device was inside the patient for approximately 30 - 40 mins.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image analysis: the images show the presence of what appears to be the sherpa guide catheter, the procedural guide wire and the spyral device present in the right and left renal arteries.There is nothing in the images to indicate any damage occurred to the sherpa guide catheter in vivo.The images do not provide any insight into the root cause of the separation of the outer layer of the guide catheter from the braided section of the wire.If information is provided in the future, a supplemental report will be issued.

• 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: 8447638
• Report Number: 1220452-2019-00032
• Device Sequence Number: 3014428
• Product Code: DQY
• UDI-Device Identifier: 00643169013520
• UDI-Public: 00643169013520
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2019

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: 05/29/2020
• Device Catalogue Number: SA6RDND1K
• Device Lot Number: 0009166760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 07/04/2019; 03/29/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 08/02/2019; 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220452-03-29-2019-001-R
• Patient Sequence Number: 1