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

Catalog Number	SCCTO110AT
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	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure via contralateral approach, the recon allegedly was not getting into the crosser.It was further reported that the crosser allegedly disconnected from the recon.Reportedly, they had to pull everything out.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2026).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during a recanalization procedure via contralateral approach, the recon allegedly was not getting into the crosser.It was further reported that the crosser allegedly disconnected from the recon.Reportedly, they had to pull everything out.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 recon support catheter loaded onto the distal end of a crosser iq catheter was received for evaluation.Product packaging and label were not returned.Upon visual evaluation, residue was noted throughout the device.Bunching and material deformation was noted to the distal end of the recon support catheter.No other anomalies were observed.Upon functional evaluation, an attempt to retrieve the recon support catheter from the crosser iq was made but it was unsuccessful.Heavy resistance was felt.No further testing was performed.Therefore, the investigation is confirmed for the reported device-device incompatibility and retraction problem as the attempt was made to retrieve the recon support catheter from the crosser iq was made but it was unsuccessful.Also, the investigation is confirmed for the identified material deformation as the bunching and deformation were noted at the distal end of the recon support catheter.A definitive root cause for the alleged retraction problem, device-device incompatibility and identified material deformation issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6(device, method).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.

• 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: 20721469
• Report Number: 2020394-2024-01710
• Device Sequence Number: 20478810
• Product Code: DQY
• UDI-Device Identifier: 00801741201295
• UDI-Public: (01)00801741201295(17)260928(10)GFHV1809
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/10/2025

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: 09/28/2026
• Device Catalogue Number: SCCTO110AT
• Device Lot Number: GFHV1809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 05/14/2025
• 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