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

Model Number	SCCTO110AT
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure, the tip of the device allegedly got frayed.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiration date: (expiration date: (b)(4) 2022) the information provided by bd 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 bd.
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 recon support catheter and empty specimen cup with fiber material inside was returned for evaluation.The distal tip of the catheter appeared to be chipped and material was noted fraying from within the catheter.The fiber material returned in the specimen cup appears to be the same as the frayed material noted at the distal end of the recon catheter.Based on the findings, the investigation is confirmed for the reported material frayed and identified improper or incorrect procedure or method issues.The returned device shows damage to the tip that may have been caused by compression when trying to change the shape of the tip.Per the instructions for use, "do not attempt to manipulate or re-shape the tip configurations." this damage likely contributed to the material on the tip of the catheter fraying.However, a definitive root cause for the reported material frayed and identified improper or incorrect procedure or method 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.Instructions for use reviewed.Precautions: ¿ carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.¿ the recon support catheter should only be used by physicians trained in percutaneous intravascular techniques and procedures.¿ verify compatibility of the recon support catheter inner and outer diameters and length with other devices before use.¿ refer to the package label for tip shape for the recon support catheters.Do not attempt to manipulate or re-shape the tip configurations.¿ exercise care in handling the recon support catheter to reduce the potential of accidental damage.¿ only use sterile saline to flush the device.¿ the geoalign marking system is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure.The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion.¿ this device is coated with a hydrophilic coating at the distal segment of the shaft.Please refer to the directions for use section for further information on how to prepare and use this device to ensure it performs as intended.Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.¿ in order to activate the hydrophilic coating, it is recommended to wet the recon support catheter with sterile saline solution immediately prior to its insertion in the body.Using different media other than the recommended solution could affect the hydrophilic coating and its performance.¿ avoid excessively wiping the coated portions of the device, or wiping with dry gauze, as this may damage the hydrophilic coating.¿ do not excessively bend, twist, or alter the shape of the device as it may compromise the integrity of the hydrophilic coating or result in device damage.¿ avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.¿ avoid pre-soaking devices for extended periods, as this may impact the coating performance.H10: b5, d4 (expiration date: 10/2022), g3, h6 (device, method).H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a recanalization procedure, the tip of the catheter allegedly got frayed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: RECON
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15101488
• Report Number: 2020394-2022-00606
• Device Sequence Number: 14599349
• Product Code: DQY
• UDI-Device Identifier: 00801741201295
• UDI-Public: (01)00801741201295
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K203275
• 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): 09/15/2022

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: SCCTO110AT
• Device Catalogue Number: SCCTO110AT
• Device Lot Number: GFFV1734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/26/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White