MAUDE Adverse Event Report: CONMED UTICA PROFORMA HG 4.5 CANN STRAIGHT 5/BX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	050906
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, 050906, proforma hg 4.5 cann straight was being used during an unknown procedure on (b)(6) 2022 and ¿when the proforma was inserted into the patient's body, the metal marker at the tip did not contrast.When the proforma was removed, the metal marker at the tip was not attached.However, the surgeon did not remember if the metal marker was attached from the beginning.¿ there was no report of impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device and there was no delay.Further assessment found that it is not known if the device was inspected before use.It is not known if a fragment fell into the patient or if the metal marker was attached from the beginning.The current status of the patient is unknown.This report is being raised on the basis of potential injury based upon the lack of information regarding if metal marker remains in patient.
Event or Problem Description
The distributor reported on behalf of the customer that the device, 050906, proforma hg 4.5 cann straight was being used during an unknown procedure on (b)(6) 2022 and ¿when the proforma was inserted into the patient's body, the metal marker at the tip did not contrast.When the proforma was removed, the metal marker at the tip was not attached.However, the surgeon did not remember if the metal marker was attached from the beginning¿.There was no report of impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device and there was no delay.Further assessment found that it is not known if the device was inspected before use.It is not known if a fragment fell into the patient or if the metal marker was attached from the beginning.The current status of the patient is unknown.This report is being raised on the basis of potential injury based upon the lack of information regarding if metal marker remains in patient.
Additional Manufacturer Narrative
Reported event is confirmed.Received one 050906 in opened original packaging.Lot number was verified.Performed a visual inspection, the metal marker at the distal tip of the device is not attached to the device and was not returned with the complaint.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 reports, regarding 3 devices, for this device family and failure mode.During this same time frame 8,200 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0004.Per the instructions for use, the user is advised the following: the proforma hf 4.5 cannula is packaged sterile in a sealed pouch.If the pouch is open or damaged, do not use or resterilize the device.After removal from the shipping package and pouch, inspect the cannula for kinks, bends, crushed areas or any other damage that may have occurred during transit.Do not use if damaged.Verify the expiration date prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PROFORMA HG 4.5 CANN STRAIGHT 5/BX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14205915
• Report Number: 1320894-2022-00085
• Device Sequence Number: 19942434
• Product Code: FGE
• UDI-Device Identifier: 40653405051412
• UDI-Public: (01)40653405051412(17)260110(10)202101111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: 050906
• Device Catalogue Number: 050906
• Device Lot Number: 202101111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic