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

Catalog Number	SCCTO110T
Medical Device Problem Codes	Entrapment of Device (1212); Material Frayed (1262); Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
8.16 h10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025).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.H3 other text : device pending return.
Event or Problem Description
It was reported that during a recanalization procedure in the tibioperoneal trunk, the support catheter was allegedly found to be lodged and would not advance to remove from the patient¿s peroneal artery with the catheter.It was further reported that the tip of the support catheter allegedly got frayed and a part got stuck in the patient's vessel wall.Reportedly, the catheter was removed with difficulty and a dissection was occurred to remove the device and additional procedure to taper and close the lesion was required.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a recanalization procedure in the tibioperoneal trunk, the support catheter was allegedly found to be lodged and would not advance to remove from the patient¿s peroneal artery with the catheter.Reportedly, the device was removed from the body with extreme difficulty.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025), g3.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.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 6fr recon support catheter loaded onto a crosser iq was returned for evaluation.During visual evaluation, hub of the support catheter was detached.Also, the distal tip of catheter and sheath was observed to be buckled/bunched.No functional test was performed.Based on the findings, the investigation is confirmed for the material deformation due to distal tip of catheter and sheath was observed to be buckled/bunched and the investigation is also confirmed for the detachment issue due to hub of the support catheter was detached.However, the investigation is inconclusive for the reported retraction issue as the condition of use cannot be replicated in the laboratory condition.A definitive root cause for the reported retraction problem and identified material deformation and detachment 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: d4 (expiration date: 09/2025), g3, h2, h6 (device) h11: h6 (method, result, conclusion) 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 in the tibioperoneal trunk, the support catheter was allegedly found to be lodged and would not advance to remove from the patient¿s peroneal artery with the catheter.Reportedly, the device was removed from the body with extreme difficulty.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 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: 17485878
• Report Number: 2020394-2023-00572
• Device Sequence Number: 7246137
• Product Code: DQY
• UDI-Device Identifier: 00801741201301
• UDI-Public: (01)00801741201301
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SCCTO110T
• Device Lot Number: GFGW2087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 11/06/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/04/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male