MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO CATH F4 INF LCB 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

While torquing and advancing a 4f 100cm left coronary bypass (lcd) infiniti diagnostic catheter, the strain relief cracked, and the body of the catheter kinked.Therefore, the device was removed, and another unknown catheter was used to complete the procedure.There was no reported patient injury.The device was intended to be used in a diagnostic catheterization procedure.Over the last 2 years this customer has been using a new technology in their procedure rooms for continued sterilization.It uses uv light while the labs aren¿t in use which is above 54 degrees.Dx & guide catheters are stored in cabinets with glass faces.One non-sterile infiniti diagnostic catheter (cath f4 inf lcb 100cm) was received for analysis.During visual inspection, a torn condition was found approximately at 74.9 cm from distal tip.Additionally, the strain relief was found cracked, and the hub was yellowish.No other anomalies were observed during the analysis.Per microscopic analysis, sem results showed the torn area of the body/shaft from the infiniti catheter presented evidence of elongations.Plastic deformation resulting in diameter reduction was observed on the braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples, plastic deformation, and the diameter reduction observed on the braid wires, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the braidwire separation.Per sem analysis on the strain relief, no evidence was observed of what could have caused the strain relief to crack.No other anomalies were observed during sem analysis.Additionally, an amplified image was taken to compare the difference in the color noted on the hub with a ¿normal¿ unit of a dx catheter.A difference is noted, since the unit involved in the complaint has a yellowish color compared to the normal hub.A product history record (phr) review of lot 17854730 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ kinked/bent - in-patient¿ was not confirmed, however, the event "catheter (body/shaft) - cracked" was confirmed since a torn/cracked condition was found, and sem results showed plastic deformation resulting in diameter reduction that was observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples, plastic deformation and the diameter reduction observed on the braid wires, are commonly associated with separations caused by material tensile overload.The reported event by the customer as ¿strain relief ¿ cracked - during use¿ was confirmed since a cracked condition was found on the strain relief.A yellowish hub was also noted which could be due to exposure to temperature conditions outside of those listed on the ifu (instructions for use).This could also lead to the cracked plastic.The exact cause of the conditions found could not be determined during analysis.Storage conditions (procedure room above 54 degrees celsius) or procedural factors might have contributed to the observed conditions reported.According to the ifu, which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ 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 Description

While torquing and advancing a 4f 100cm left coronary bypass (lcd) (b)(6) diagnostic catheter, the strain relief cracked, and the body of the catheter kinked.Therefore, the device was removed, and another unknown catheter was used to complete the procedure.There was no reported patient injury.Scanning electron microscope (sem) analysis performed on the returned device also showed a torn/separated area of the body/shaft.The device was intended to be used in a diagnostic catheterization procedure.Over the last 2 years this customer has been using a new technology in their procedure rooms for continued sterilization.It uses uv light while the labs aren¿t in use which is above 54 degrees.Dx & guide catheters are stored in cabinets with glass faces.The device will be returned for evaluation.

• Brand Name: CATH F4 INF LCB 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12289655
• MDR Text Key: 265589568
• Report Number: 9616099-2021-04765
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014908
• UDI-Public: (01)10705032014908(17)220331(10)17854730
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 538472
• Device Lot Number: 17854730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1