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

Catalog Number	SA6IMAK
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2019
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 sherpa guide catheter was intended to be used during a renal denervation procedure to treat a lesion in the ostium renal artery.A femoral approach was used.There was no damage noted to packaging, and no issues removing the device from the packaging as per ifu.The device was inspected and prepped per ifu with no issues.It was reported that resistance was experienced during use, whilst inserting the device through a 6f non-medtronic introducer sheath.The device was not excessively torqued.Resistance was also felt when maneuvering for engagement of the renal artery.Excessive force was not used.The physician removed the guide catheter after the first attempt and noted that there was damage to the distal portion of the device.It was also noted that there was debris outside of the introducer sheath.The device was only attempted to be used once.It is stated that the device was not re-sterilized.Aspiration was not performed in the procedure.The physican exchanged the sherpa device with a 5f non-medtronic pigtail catheter for an aortogram.A 6f sa6rdnd1k sherpa guide catheter was then introduced and the physician felt resistance during insertion.At this point the physician decided to change to a 7f introducer sheath.The physician continued with the 6f rdnd1 device, and that was exchanged afterwards with a 6f ima to engage the renal artery.The procedure was continued with a spyral catheter insertion until it was completed.No patient injury reported.Devices are stored in a secured, locked room close to the cath lab away from any light source and chemicals.The guide catheter was not wiped at any stage.
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
Image review: product received match the photos provided.Product analysis summary: the analysis revealed damage to one of the segments of the catheter distal end.The damage consisted of delamination of the material covering the braid, resulting in exposing the braid of the distal shaft.Actual physical measurement of the returned 6f sherpa tip inner diameter 0.70¿, outer diameters: shaft.0822¿, segments 0.083¿, over sleeve.0862¿ and tip.0818¿ met specifications.The proximal segment and the distal tip over sleeve were undamaged.Also received was a bloody 6f non-medtronic introducer sheath, no damage was noted the sheath.A tiny piece of likely the dislodged segment material was detected on the outside surface of the hub of the sheath.Introducer sheath inner measurement taken on the sheath 0.084¿.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: 8347501
• Report Number: 1220452-2019-00015
• Device Sequence Number: 13933962
• Product Code: DQY
• UDI-Device Identifier: 00613994824059
• UDI-Public: 00613994824059
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 04/04/2020
• Device Catalogue Number: SA6IMAK
• Device Lot Number: 0009066696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/08/2019; 01/29/2019; 03/08/2019; 03/29/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/29/2019; 04/09/2019; 07/09/2019; 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: 61 YR
• Patient Weight: 86