MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 6F 10CM HW RADIAL; INTRODUCER, CATHETER

Model Number	506610H
Medical Device Problem Code	Unraveled Material (1664)
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 mini guidewire of the 6f 10cm hydrophillic wire (hw) transradial rain sheath introducer got stuck in its tube.The sales rep mentioned that the device was damaged and was unusable.There was no reported patient injury.The device was stored in the cath lab for one week.Additional procedural details were requested but are unknown.The product was returned for analysis.Previously a picture analysis was performed with the following result: a file with a picture of a tray inner packaging pouch of a 6f 10cm hw radial catheter sheath introducer was received for visual review attached to the complaint (b)(4).The part number was confirmed as 506610h and lot number 17971292.Per visual analysis of the picture attached to the complaint, no anomalies could be observed.When the product was received at the pal laboratory the analysis results are listed below: a non-sterile mini guidewire which is part of a ¿6f 10cm hw radial¿ was received coiled inside of a clear plastic bag.Per visual analysis, the coil wire presented an unraveled\stretched condition observed at the 2 cm from the distal core wire (ribbon).No other damages or anomalies were observed on the returned guidewire.The damage area was inspected using a vision system to obtain a magnified image confirming the unravel/stretched condition of the returned unit.A product history record (phr) review of lot 17971292 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿mini guidewire unraveled/stretched¿ was confirmed during analysis of the returned device.An unraveled\stretched condition was observed at the distal core wire (ribbon).The exact cause of the reported event could not be conclusively determined.Procedural/handling factors might have contributed to this issue.According to the instructions for use (ifu) which is not intended as a mitigation of risk, users are instructed to inspect for damage prior to use in the patient.Neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, the mini guidewire of the 6f 10cm hydrophillic wire (hw) transradial rain sheath introducer got stuck in its tube.The sales rep mentioned that the device was damaged and was unusable.Product evaluation confirmed that the coil wire presented an unraveled\stretched condition observed at the 2 cm from the distal core wire (ribbon).There was no reported patient injury.The device was stored in the cath lab for one week.The device will be returned for analysis.Additional procedural details were requested but are unknown.

• Brand Name: 6F 10CM HW RADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico ; MX
• MDR Report Key: 11619523
• Report Number: 9616099-2021-04390
• Device Sequence Number: 16966961
• Product Code: DYB
• UDI-Device Identifier: 10705032079037
• UDI-Public: 10705032079037
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 08/31/2023
• Device Model Number: 506610H
• Device Catalogue Number: 506610S
• Device Lot Number: 17971292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1