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	05/26/2019
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 one side.A 0.038¿ wire was passed through the catheter with resistance noted at the kinked section of the catheter.The id and 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
During a procedure a 7f sherpa balanced guide catheter was used to treat a lesion.There was no damage noted to the device packaging.The device was removed from the packaging as per ifu.The device was inspected with no issues noted.The device was prepped as per ifu with no issues.Resistance was not encountered when advancing the device and excessive force was not used during delivery.The device was not excessively torqued.It was reported that the catheter was kinked from the primary curve while in the patient.The patient is alive with no injury.Analysis on the returned device found that the device wire braid was exposed at the proximal side hole with segment material split on one side.

• 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: 8938736
• Report Number: 1220452-2019-00105
• Device Sequence Number: 16758968
• 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): 08/28/2019

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: 0009566691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1