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	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: as received the distal segment material is missing, exposing the braid wire.Flakes of the light blue segment material could easily be lifted away from the braid with tweezers.The material is very soft.The material gets more firm and rubbery closer to the proximal segment transition and distal segment transition.Inner lumen showing some of the liner disturbed.The introducer as received was full of blood.It was flushed into a strainer and only a small blood clot was found, no particles from the catheter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sa6imak sherpa guide catheter was attempted to be used in a renal denervation procedure.There was no damage noted to the device packaging.The device was removed from the packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.The device was inserted through a 6f non-medtronic introducer sheath over a 0.035" wire.The physician stated that it felt normal as it was inserted through a sheath.Resistance was not encountered when advancing the device and excessive force was not used.The device was advanced through the femoral sheath to the aorta.It is stated that the guide catheter was not offering support.The wire was pulled back and the physician didn't like how the guide looked so it was pulled out to be inspected.It is reported that when the wire was pulled back it was noted that the guide tip did not have its typical ima unsupported shape and it was mostly straight in line with shaft.The guide was removed to examine the tip and it was noted that the outer coating had been removed near the tip of the guide and the wire braiding was exposed.It is stated that the device was removed shortly after insertion.After the guide was removed the physician aspirated blood through the introducer sheath and noticed 1-2 very small blue particles that appeared to be fragments of the catheter.It cannot be confirmed if all particles were removed from the patient.The renal arteries were not cannulated.No patient injury is reported.The sherpa device was not re-sterilized.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 8469242
• Report Number: 1220452-2019-00037
• Device Sequence Number: 1432123
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2019
• Device Catalogue Number: SA6IMAK
• Device Lot Number: 0008757848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 04/18/2019; 03/29/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/14/2019; 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: 51 YR
• Patient Weight: 93