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

Catalog Number	SD110AT
Medical Device Problem Codes	Bent (1059); Retraction Problem (1536); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 during a cto crossing procedure in the left sfa, the support catheter allegedly would not advance towards the lesion and the recanalization catheter allegedly would not retract through the support catheter.It was further reported that the health care provider (hcp) removed the recanalization and support catheters together as a single unit.The hcp attempted to cross the proximal cap with a guidewire but was unsuccessful; therefore, the procedure was concluded and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were 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 event reported to date for this lot number and failure mode.Investigation summary: the device was returned.The investigation was confirmed for failure to retract as the recanalization catheter was stuck inside the support catheter.The investigation was also confirmed for buckled material and bend, as the support catheter was bunched and bent.The investigation was inconclusive for failure to advance as functional testing was unable to be performed.The root cause could not be determined based upon available information.It was unknown whether patient and/or procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) state: when using the tapered sidekick catheter with the crosser catheter 14s or 14p, the crosser catheter can be advanced approximately 15cm from the tip of the sidekick catheter.Resistance is encountered beyond 15cm due to the taper on the crosser catheter aligning with the taper on the sidekick catheter.A taper lock-up marker (single marker on the crosser catheter shaft) is located 127cm from the distal tip for the 146cm crosser catheter and 80cm from the distal tip for the 106cm crosser catheter.The taper lock-up marker is an indicator that the tapers on the catheters are nearing alignment; advance the crosser catheter slowly.Do not continue to advance the crosser catheter if resistance is encountered.Procedural steps: remove product using standard techniques while maintaining guidewire access when use of the product is complete.
Event or Problem Description
It was reported that during a cto crossing procedure in the left sfa, the support catheter allegedly would not advance towards the lesion and the recanalization catheter allegedly would not retract through the support catheter.It was further reported that the health care provider (hcp) removed the recanalization and support catheters together as a single unit.The hcp attempted to cross the proximal cap with a guidewire but was unsuccessful; therefore, the procedure was concluded and no further treatment was provided.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: 7267667
• Report Number: 2020394-2018-00089
• Device Sequence Number: 13951720
• Product Code: DQY
• UDI-Device Identifier: 00801741067815
• UDI-Public: (01)00801741067815
• 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,Followup
• Report Date (Section B): 04/09/2018

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: 01/31/2019
• Device Catalogue Number: SD110AT
• Device Lot Number: GFZI3243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1