MAUDE Adverse Event Report: MEDTRONIC, INC SHERPA BALANCED 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	SB7JL40SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis? received for analysis was one 7f sherpa balanced guide catheter sb7jl40sh, lot# 0009539885, coil wrapped with original packaging.As received the catheter was clean, no blood, no kinks in the shaft or segment curve area.The proximal side hole was damaged.The segment material was damaged on both sides of the sidehole.The distal side hole was not damaged.Sharp edges are visible around the edge of the sidehole.It does not appear that there is any missing material around the proximal sidehole.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 procedure.No damage noted to packaging.It is reported that the side hole section of the device was fractured while passing through an introducer sheath.It was stated that no portion of the device detached.It was noted that the catheter's curve section was very quickly damaged when manipulating (bending-straightening) the catheter.The device was not used in the patient.The catheter was removed from the outer box and hung up.

• Brand Name: SHERPA BALANCED 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9346102
• Report Number: 1220452-2019-00145
• Device Sequence Number: 19533405
• Product Code: DQY
• UDI-Device Identifier: 00613994835383
• UDI-Public: 00613994835383
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K051846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: 01/14/2021
• Device Model Number: SB7JL40SH
• Device Catalogue Number: SB7JL40SH
• Device Lot Number: 0009539885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1