MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 6F10CM NW RADIAL; INTRODUCER, CATHETER

Model Number	506610N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 18001776 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, that during a left heart catheterization (lhc) procedure, the doctor attempted to gain access into the radial artery and when he tried to insert the wire of 6f 10cm transradial rain sheath introducer it would only go so far and then not advance anymore.They tried gaining access for approximate 20 minutes.When they tried to remove the wire through the needle, it was reported that the wire was stuck and would not come out.Another doctor was eventually called in to the room to try to assist.At some point the wire was removed, but the tip of the wire had broken off and the new distal end had sheared.A vascular surgeon was called in to try and retrieve the distal tip but was not successful.They performed a cut down of the artery and as reported by the tech, the distal tip was not visible in the artery but was retrieved from the muscle.Another nurse in the room had the same account of the procedure, however, the vascular surgeon did not dictate that in his notes.The patient was ok and went home the same day.Therefore, the left heart catheterization (lhc) procedure was completed by going in through the femoral artery access.The operator was trained to the transradial rain sheath introducer device.The device was stored in the cath lab with the rest of their product, for a few weeks.The device 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 noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was difficulty gaining access.The wire kinked while being used.The lesion was sot calcified or tortuous.The device was not used for a chronic total occlusion.The device will be returned for evaluation.
Additional Manufacturer Narrative
During a left heart catheterization (lhc) procedure, the doctor attempted to gain access into the radial artery and when he tried to insert the wire of 6f 10cm transradial rain sheath introducer it would only go so far and then not advance anymore.They tried gaining access for approximate 20 minutes.When they tried to remove the wire through the needle, it was reported that the wire was stuck and would not come out.Another doctor was eventually called in to the room to try to assist.At some point the wire was removed, but the tip of the wire had broken off and the new distal end had sheared.A vascular surgeon was called in to try and retrieve the distal tip but was not successful.They performed a cut down of the artery and as reported by the tech, the distal tip was not visible in the artery but was retrieved from the muscle.Another nurse in the room had the same account of the procedure, however, the vascular surgeon did not dictate that in his notes.The patient was ok and went home the same day.The left heart catheterization (lhc) procedure was completed by going in through the femoral artery access.The operator was trained using the transradial rain sheath introducer device.The device was stored in the cath lab with the rest of their products, for a few weeks.The device 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 noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was difficulty gaining access.The wire kinked while being used.The lesion was sot calcified or tortuous.The device was not used for a chronic total occlusion.The device was returned for analysis.Per visual analysis, a non-sterile unknown (non-cordis) mini guidewire was received inside a clear plastic bag.The guidewire does not belong to the ¿6f10cm nw radial¿ cordis kit.The needle was also not included in the shipment.No other analysis was performed.A product history record (phr) review of lot 18001776 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿mini guidewire ~ fractured-separated - in patient¿ could not be confirmed since the needle was not retuned for analysis and the included mini guidewire is an unknown (non-cordis) product.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator technique, may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.Recommended procedure: introduce the needle into the vessel using an aseptic technique.Holding the needle in place, insert the flexible end of the mini guidewire through the needle and into the vessel.Gently advance the guidewire to the desired depth.Do not withdraw the guidewire back though the metal cannula of the needle after it has been inserted as it may damage the guidewire.¿ a 0.021 diameter mini guidewire is provided for establishing vessel access.The mini guidewire is bare (stainless steel), nitinol, polymer, or hydrophilic coated depending on the kit configuration.An iv catheter access needle is also provided with the hydrophilic wire and polymer wire kit options to facilitate initial entry into the artery.Additionally, the ifu warns users ¿if using a hydrophilic or polymer wire, do not use with a bare needle, as this may damage the integrity of the coating or jacket.Manipulate the mini-guidewire slowly and carefully to avoid damage to the vessel wall, while monitoring the tip position and movement using standard catheterization technique.Do not manually re-shape the tip of the mini-guidewire by applying external force intended to bend or affect the shape of mini-guidewire.¿ since the mini guidewire is an unknown non-cordis product, and the needle is unknown as well, it is hard to make a clinical conclusion between the devices and the reported events based on the information available.Neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.The initial reporter also sent report to fda: mw5101892.

• Brand Name: 6F10CM NW RADIAL
• 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: 12121771
• Report Number: 9616099-2021-04680
• Device Sequence Number: 4764073
• Product Code: DYB
• UDI-Device Identifier: 10705032082167
• UDI-Public: 10705032082167
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 01/31/2024
• Device Model Number: 506610N
• Device Catalogue Number: 506610N
• Device Lot Number: 18001776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR