MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SI BRITE TIP 6F 11CM STR; INTRODUCER, CATHETER

Model Number	401611M
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the distal end of a 6f 11cm straight (str) brite tip sheath introducer was fractured.The damage was noticed after use.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The lesion had little calcification.There was over fifty percent stenosis.The device was not used for a chronic total occlusion (cto).The device was safely stored.The product was stored, handled and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was no resistance advancing the product to the lesion.There was no resistance met while withdrawing the device.There was no unusual force used at any time during the procedure.The product was not returned for analysis.A product history record (phr) review of lot 17952887 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip cracked - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Procedural factors, may have contributed to the reported event.According to the product instructions for use which is not intended as a mitigation of risk, users are cautioned that if increased resistance is felt upon insertion or withdrawal of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.Neither the phr review nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, the distal end of a 6f 11cm straight (str) brite tip sheath introducer was fractured.The damage was noticed after use.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The lesion had little calcification.There was over fifty percent stenosis.The device was not used for a chronic total occlusion (cto).The device was safely stored.The product was stored, handled and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was no resistance advancing the product to the lesion.There was no resistance met while withdrawing the device.There was no unusual force used at any time during the procedure.The device will not be returned for evaluation as it was discarded.The device will not be returned for evaluation as it was discarded.

• Brand Name: SI BRITE TIP 6F 11CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10988387
• Report Number: 9616099-2020-04116
• Device Sequence Number: 16316307
• Product Code: DYB
• UDI-Device Identifier: 20705032000236
• UDI-Public: 20705032000236
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 05/31/2023
• Device Model Number: 401611M
• Device Catalogue Number: 401611M
• Device Lot Number: 17952887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 65