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

Model Number	SA6JR40SH
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
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 used.No damage was noted to the device packaging or the protective packaging.The device was not inspected prior to use.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that there was loss of the distal segment outer material.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the catheter was unable to be positioned in the ostium of the rca and when pulled back it was noted that the distal segment (last 20 cm) was deformed, the most part of the catheter was missing with the wire braid exposed.No patient injury reported.Image analysis: photo provided matched the product returned.The catheter distal segment material is missing, exposing the braid wire.Product analysis: received for analysis was 6f sherpa catheter sa6jr40sh lot# 0008777263.As received the catheter was coil wrapped and bloody.The catheter distal segment material is missing, exposing the braid wire.There is visible degradation/disintegration of 35d pebax distal segment.Remaining segment material is visible cracked and loose.Flakes of the light blue segment material could easily be lifted away from the braid with tweezers.The material is very soft.Tip and sleeve are intact.Shaft and inner lumen are intact.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: 8636295
• Report Number: 1220452-2019-00066
• Device Sequence Number: 19293897
• Product Code: DQY
• UDI-Device Identifier: 00613994821850
• UDI-Public: 00613994821850
• 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: Other
• 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: 08/30/2019
• Device Model Number: SA6JR40SH
• Device Catalogue Number: SA6JR40SH
• Device Lot Number: 0008777263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/27/2019; 03/29/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/26/2019; 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