MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE; CLAMP, VASCULAR

Model Number	CV1161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.Date of event: date of event was unknown.Bd awareness date was used.Address/city: the address of the reporter was not provided.Unknown was used as a filler for these fields.
Event or Problem Description
Flexible aortic vascular clamp was used to cross clamp the aorta and arrest the heart during a cardiopulmonary bypass procedure broke into multiple pieces while it was in situ.Surgeon and the scrub nurse were able to retrieve all the visible parts and handed over to the circulating nurse.No patient injury or harm reported.
Additional Manufacturer Narrative
Pr (b)(4) supplemental emdr.There was no sample or photo available to bd for evaluation after multiple attempts were made to return it.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.We appreciate you taking the time to bring this observation to our attention.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Date of event: date of event was unknown.Bd awareness date was used.Address/city: the address of the reporter was not provided.Unknown was used as a filler for these fields.H3 other text : device not available for evaluation.
Event or Problem Description
Flexible aortic vascular clamp was used to cross clamp the aorta and arrest the heart during a cardiopulmonary bypass procedure broke into multiple pieces while it was in situ.Surgeon and the scrub nurse were able to retrieve all the visible parts and handed over to the circulating nurse.No patient injury or harm reported.
Additional Manufacturer Narrative
Pr (b)(4) supplemental emdr.Correction provided.Date of event was updated due to new information provided by the customer.Initial reporter information was updated as the distributor provided the customer's contact information.Address of the facility was updated as unknown since the facility's address was not provided with the updated information.H3 other text : device not available for evaluation.
Event or Problem Description
Flexible aortic vascular clamp was used to cross clamp the aorta and arrest the heart during a cardiopulmonary bypass procedure broke into multiple pieces while it was in situ.Surgeon and the scrub nurse were able to retrieve all the visible parts and handed over to the circulating nurse.No patient injury or harm reported.

• Brand Name: COSGROVE FLEX QCK-BEND 61MM 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13169855
• Report Number: 1423507-2022-00001
• Device Sequence Number: 4505868
• Product Code: DXC
• UDI-Device Identifier: 10885403036286
• UDI-Public: (01)10885403036286
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 11/16/2022

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: CV1161
• Device Catalogue Number: CV1161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 02/08/2022; 11/16/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/10/2022; 12/13/2022
• 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: Other; Other
• Patient Sex: Unknown