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

Catalog Number	SB7EBU375SH
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
Product analysis: one 7f sherpa guide catheter was received for analysis.The device was kinked at the proximal side hole.Wire braid was exposed at the proximal side hole and the segment material was split on both sides.A 0.038¿ wire was passed through the catheter with no resistance noted.The id measured 0.080¿ the od measured 0.094¿, both meeting specification.No other deformation was noted to the device.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.It was reported that the catheter quickly kinked at the primary curve when the guide liner was being passed through the sherpa.No patient injury reported.Analysis of the returned device revealed that the wire braid was exposed at the proximal side hole and the segment material was split on both sides.

• 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: 8948769
• Report Number: 1220452-2019-00107
• Device Sequence Number: 2768883
• Product Code: DQY
• UDI-Device Identifier: 00613994837547
• UDI-Public: 00613994837547
• 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
• Report Date (Section B): 08/30/2019

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: 01/29/2021
• Device Catalogue Number: SB7EBU375SH
• Device Lot Number: 0009566692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR