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

Catalog Number	SA6IMAK
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
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 sa6imak sherpa guide catheter was intended to be used during a renal denervation procedure in the ostium of the renal arteries, exhibiting no calcification and no stenosis.There was no damage noted to packaging.No issues removing the device from packaging as per ifu.The device was not inspected.The device was prepped per ifu with no issues.A 6f 25cm 2cm non-medtronic sheath was used.Slight resistance was noted when inserting the sherpa device.The sherpa was inserted over a guide wire but not devices were delivered through the sherpa.No resistance was encountered when advancing the device and no excessive force was used during the delivery.It is reported that the device would not seat at the aorta so the physician decided to remove the device.When removed, it was noted that the tip of the catheter was exposed and the blue sleeve coating was missing.The device did not retain its shape.This occurred after the first attempt to use the device.It is stated that the guide catheter was inside the patient for two minutes.The outside of the guide catheter was not wiped at any stage.The sherpa device was not re-sterilized.Aspiration was not performed in the procedure.No further patient injury is reported.It is stated that no fragments of the sherpa device remain in the patient.The catheter did not get into the renal arteries, it was only in the aorta before it was removed.A sa6rdnd1k sherpa device was also used in the procedure.There is no alleged issue/malfunction being reported for this device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the photo provided by customer is consistent with returned sample, degradation/disintegration of 35d pebax distal segment.Product analysis: distal end opposing sides shows degradation/disintegration of 35d pebax distal segment.2/3 of the segment is missing exposing the braid wire.Tip and sleeve are intact.Shaft and inner lumen is intact.Flakes of material easily came off and were smeared on paper towel.The material is soft.The material closer to the tip sleeve is firmer.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: 8448402
• Report Number: 1220452-2019-00033
• Device Sequence Number: 3056664
• Product Code: DQY
• UDI-Device Identifier: 00613994824059
• UDI-Public: 00613994824059
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 11/20/2019
• Device Catalogue Number: SA6IMAK
• Device Lot Number: 0008889534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 03/29/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/16/2019; 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
• Patient Age: 64 YR
• Patient Weight: 98