MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX QCK-BEND 86MM FOGARTY-TYPE; CLAMP, VASCULAR

Catalog Number	CV1186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # 8641612 - medwatch # (b)(4).14aug2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
Customer reported while surgeon using instrument to cross-clamp the aorta, cable in the instrument broke and small pieces (beads) dispersed in multiple directions.Staff unsure of location of all beads.Instrument immediately removed from field.Field and cavity searched.Xray obtained prior to closure to ensure no beads from broken instrument were inside chest cavity.Xray for foreign body performed.Results read; no foreign body detected.No further information is not available.

• Brand Name: COSGROVE FLEX QCK-BEND 86MM FOGARTY-TYPE
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: andrew elia ; 5 sunnen drive; st. louis, MO 63143 ; 8015652341
• MDR Report Key: 17580719
• Report Number: 1923569-2023-00011
• Device Sequence Number: 12828923
• Product Code: DXC
• UDI-Device Identifier: 10885403036293
• UDI-Public: (01)10885403036293
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K210324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2023
• Report Date (Section F): 08/18/2023

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 Catalogue Number: CV1186
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown