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

Model Number	SB7JL35SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sherpa guide catheter was attempted to be used.There was no damage noted to the device packaging.The device was removed from the packaging per ifu with no issues.The device was not inspected.The device was prepped with no issues.Resistance was not encountered when advancing the device and excessive force was not used.The device was excessively torqued.It was reported that the catheter was quickly kinked in the middle when it was being torqued in the patient.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: received for analysis was a device in a plastic bag labelled with lot number: 0009528032.A torsional kink was noted on the shaft 17 cm distal to the strain relief.The id and the od measurements both meet specification.No other deformation was noted to the device.If information is provided in the future, a supplemental report will be issued.

• 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: 8673922
• Report Number: 1220452-2019-00072
• Device Sequence Number: 16734156
• Product Code: DQY
• UDI-Device Identifier: 00613994835444
• UDI-Public: 00613994835444
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 01/07/2021
• Device Model Number: SB7JL35SH
• Device Catalogue Number: SB7JL35SH
• Device Lot Number: 0009528032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR