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

Model Number	SA6IMAK
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: received for analysis was one 6f sherpa guide catheter sa6imk lot# 0008242787 in original packaging.As received the catheter is kinked mid shaft, and the distal segment is damaged and missing the outer segment material approximately 1.5cm in length.Distal segment material is missing exposing braid all the way around.The braid and inner liner is bunched up due to the lack support by the missing outer distal segment.There is a small portion of segment material left at the proximal edge of the tip sleeve.Some of the segment material is lifted and flaking and loose.The tip, tip sleeve, secondary segment and shaft materials appear to be undamaged and without defect.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a sherpa guide catheter.There was no damage noted to packaging.The device was removed from the packaging per the ifu with no issues.Resistance was encountered and the device failed to be inserted into the introducer sheath.It is reported that when the catheter was extracted it was noted that at the distal part of the catheter the double braid was not covered by the jacket.No part of the catheter was inserted into the introducer.The tip of the catheter was not advanced beyond the introducer tip.No excessive force was used.The exposed braid was not noticed prior to insertion into the introducer.The inspection was carried out after the resistance was noted and after the catheter had been extracted.No patient injury is reported.The account did not see any of the blue segment material on the drape or entrance of the introducer.When the exposed braid was noted the introducer was not switched.The issue was noticed because the catheter couldn't be inserted into the introducer sheath.The catheter was not wiped on the outside with anything.The catheter did not come into contact with an implanted device.The catheter was not cleaned prior to shipment for analysis.The catheter was not used for more than one case.The catheter was not re-sterilized.The device is stored on a normal shelf at the facility.The device was removed from outer box and left lying flat on the table.Before removing the catheter from the plastic envelope the device was flushed with saline.The case report is not available.Cine images are not available.It is unknown what medications the patient was on.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.

• 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: 8925405
• Report Number: 1220452-2019-00099
• Device Sequence Number: 10826353
• Product Code: DQY
• UDI-Device Identifier: 00613994824059
• UDI-Public: 00613994824059
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 09/30/2018
• Device Model Number: SA6IMAK
• Device Catalogue Number: SA6IMAK
• Device Lot Number: 0008242787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 08/23/2019
• 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