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

Model Number	SA6EBU45
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: received for analysis was 6f sherpa catheter sa6ebu45 with original packaging lot number 0008682938 matching the complaint file.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.
Event or Problem Description
A sherpa guide catheter was intended to be used.There was no damage noted to the device packaging.The device was inspected with issues noted.It was reported that the distal outer layer was detached from the inner layer.The device was not used in the patient.At the facility devices are stored in a closet in the boxes away from any light source.When devices are received at the account they are stored in the warehouse.Devices are not wiped at any stage at the account.It was reported that the device was not used in the patient however the damage observed indicates that an attempt may have been made to insert the device into the introducer.
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: 8925432
• Report Number: 1220452-2019-00100
• Device Sequence Number: 1948839
• Product Code: DQY
• UDI-Device Identifier: 00613994824639
• UDI-Public: 00613994824639
• 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
• Report Date (Section B): 10/22/2019

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: 06/16/2019
• Device Model Number: SA6EBU45
• Device Catalogue Number: SA6EBU45
• Device Lot Number: 0008682938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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