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

Model Number	SB7AL10SH
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device returned in plastic bag.A flexural kink was noted at the proximal side hole.Wire braid was visible.The id and the od measurements both met 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 per ifu with no issues.Resistance was not encountered when advancing the device and excessive force was not used.The device was not excessively torqued.It was reported that the catheter was quickly kinked from the primary curve.The kink occurred while the device was in the patient.No patient injury reported.Analysis of the returned device revealed a flexural kink with wire braid exposed.

• 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: 8929290
• Report Number: 1220452-2019-00104
• Device Sequence Number: 18892830
• Product Code: DQY
• UDI-Device Identifier: 00613994836816
• UDI-Public: 00613994836816
• 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): 08/26/2019

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: 08/09/2020
• Device Model Number: SB7AL10SH
• Device Catalogue Number: SB7AL10SH
• Device Lot Number: 0009274591
• 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: 07/29/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1