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

Model Number	SB7EBU30
Medical Device Problem Codes	Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #: 250289860: two still images were received for analysis.From the images provided it appears a kink is evident on the catheter on the secondary segment of the distal curve.It is not clear from the images provided whether there is any other damage to the catheter.Product analysis #: 252282311: received for analysis was one 7f sherpa guide catheter.The 0.035¿ wire used during the procedure was not returned.Kinks were noted along the full length of the shaft, located approx.15, 19.5, 26-28, 36.5, 40.5, 55, 72.5, and 77cm from the strain relief.A kink was noted on the distal curve approx.95.5cm from the strain relief.A kink was noted on the secondary segment of the distal curve located approx.97cm from the strain relief.The braiding was exposed at this kink site.The id measured 0.080¿ meeting specification of 0.080¿ +/- 0.001¿.The od measured 0.093¿ meeting specification of 0.094 +/- 0.001¿.An attempt was made to load an inhouse 0.035¿ wire through the catheter, and the wire could not advance past the first site of deformation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sherpa guide catheter was used during a procedure.No damage was noted to the protective package.No resistance was noted while removing the device from packaging.The device was not inspected after removal from packaging.Force was not used during the insertion/delivery of the device.Resistance was felt when attempting to insert a 0.035 guidewire through the sherpa.It was reported that the device was kinked between the secondary and primary curve in the mid tone blue (at end of dark blue and beginning of next shade of blue.The device was removed when the resistance was felt.The device was used in the patient.No patient injury was reported.

• 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: 9927649
• Report Number: 1220452-2020-00039
• Device Sequence Number: 2827788
• Product Code: DQY
• UDI-Device Identifier: 00613994836571
• UDI-Public: 00613994836571
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: 06/11/2020
• Device Model Number: SB7EBU30
• Device Catalogue Number: SB7EBU30
• Device Lot Number: 0009184660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1