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

Catalog Number	SB7EBU40SH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was intact, no portion was detached.Deformation was evident to the proximal side hole.One 7f sherpa guide catheter was received for analysis.There was damage evident to the proximal sidehole.The sidehole appeared severely kinked on one side, resulting in splitting of the outer jacket and exposure of wire braid.There does not appear to be any missing material from the outer jacket of the device.No part of the catheter was detached.No damage noted to the distal sidehole.No other deformation noted to the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 7 fr sherpa balanced guide catheter was intended to be used.There was no damage noted to the device packaging.The device was inspected with no issues noted.The device was prepped as per ifu.It was reported that a portion of the device detached during prep.The device manipulated during prep.An attempt was made to insert the device into the introducer.The device was not used in the patient.

• 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: 9537413
• Report Number: 1220452-2020-00001
• Device Sequence Number: 2335178
• Product Code: DQY
• UDI-Device Identifier: 00613994837493
• UDI-Public: 00613994837493
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: 10/31/2020
• Device Catalogue Number: SB7EBU40SH
• Device Lot Number: 0009415765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1