MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) SIDEKICK SUPPORT CATHETER

Catalog Number	SD70ATG
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
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 device was not returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 treatment of a lesion site in the popliteal, the recanalization catheter allegedly became stuck in the support catheter's sheath.It was further reported that the recanalization catheter and the support catheter were allegedly removed.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
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.Investigation summary: the investigation was inconclusive for retraction problem as the device was not returned.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: product length selection and procedural notes: 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 treatment of a lesion site in the popliteal, the recanalization catheter allegedly became stuck in the support catheter's sheath.It was further reported that the recanalization catheter and the support catheter were allegedly removed.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: SIDEKICK SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV); KS
• MDR Report Key: 7170139
• Report Number: 2020394-2017-01888
• Device Sequence Number: 16617055
• Product Code: DQY
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• Combination Product (Y/N): N
• PMA/510(K) Number: K161986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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: 05/28/2020
• Device Catalogue Number: SD70ATG
• Device Lot Number: GFBR3676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2047
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1