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

Model Number	SD110ATG
Medical Device Problem Codes	Retraction Problem (1536); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2023).
Event or Problem Description
It was reported that during a recanalization procedure via superficial femoral artery , the catheter was allegedly had retraction issue.It was further reported that the device was allegedly had incompatibility issue.Reportedly the device allegedly deformed.The catheter and wire removed as a single unit and lost wire access.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one sidekick crossing support catheter loaded onto the crosser catheter was returned for evaluation.Sidekick was noted to be warped and bunching at the distal tip.An attempt was made to remove the sidekick loaded onto the crosser but was unsuccessful.Based on the findings, the investigation is confirmed for the reported retraction problem, device-device incompatibility and material deformation issues.A definitive root cause for the reported retraction problem, device-device incompatibility and material deformation issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2023), h11: h6 (result, conclusion), h11: section a through f ¿ the information provide by bd represents all 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 bd.H3 other text : see h10.
Event or Problem Description
It was reported that during a recanalization procedure via superficial femoral artery , the catheter allegedly had incompatibility issue and retraction issue.It was further reported that the device was allegedly deformed.The catheter and wire removed as a single unit and lost wire access.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: SIDEKICK
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14038229
• Report Number: 2020394-2022-00270
• Device Sequence Number: 4629099
• Product Code: DQY
• UDI-Device Identifier: 00801741124884
• UDI-Public: (01)00801741124884
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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 Model Number: SD110ATG
• Device Catalogue Number: SD110ATG
• Device Lot Number: GFEV0283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown