MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIDEKICK SUPPORT CATHETER

Catalog Number	SD110A
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one sidekick was returned for evaluation.The returned device was visually inspected, which identified the outer catheter of the device to be twisted.In the area of twisting, the outer catheter was noted to be broken, exposing the metal braiding of the device.Therefore, the investigation can be confirmed for the alleged twisted material and additionally confirmed for the identified break.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that the support catheter was used along with a recanalization catheter to cross a heavily calcified sfa.The support catheter allegedly became twisted during usage.It was further reported that the procedure was completed with another recanalization catheter.There was no reported patient injury.

• Brand Name: SIDEKICK SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7599160
• Report Number: 2020394-2018-00864
• Device Sequence Number: 2066717
• Product Code: DQY
• UDI-Device Identifier: 00801741067808
• UDI-Public: (01)00801741067808
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 04/30/2019
• Device Catalogue Number: SD110A
• Device Lot Number: GFAQ2157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1