MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534550S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/15/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17948892 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 110cm 6 side holes (6sh) infiniti pigtail (pig) diagnostic catheter was broken in half when it was removed from the packaging.In addition, the packaging was also broken.There was no reported patient injury.The device was opened in a sterile field.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, g3, g6, h1, h2, h3 and h6 as reported, a 5f 110cm 6 side holes (6sh) infiniti pigtail (pig) diagnostic catheter was broken in half when it was removed from the packaging.Additionally, the packaging was also broken.The device was opened in a sterile field.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17948892 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer events, ¿catheter (body/shaft)- separated - during prep¿ and ¿packaging/pouch/box- damaged¿ could not be confirmed.Shipping/handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Exposure to temperatures above 54°c (130°f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Addendum to complaint conclusion to include product evaluation results: as reported, the 5f 110cm 6 side holes (6sh) infiniti pigtail (pig) diagnostic catheter was broken in half when it was removed from the packaging.In addition, the packaging was also broken.There was no reported patient injury.The device was opened in a sterile field.One non-sterile cath f5 inf pig 110cm 6sh unit was received for analysis inside a plastic bag.During visual inspection, a separated condition on the body/shaft was noted approximately 33.9 cm from the distal tip.The original packaging was not returned.Sem analysis was performed on the affected area of the returned unit.Evidence of elongations and a flared condition to the separated area of the body/shaft was noted.Additionally, ductile dimples and a cup and cone-like shape was observed on the separated braid wire surfaces.A product history record (phr) review of lot 17948892 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer, ¿packaging/pouch/box ¿ damaged¿ was not confirmed since the original packaging was not returned for evaluation.The reported event, ¿catheter (body/shaft) ¿ separated - during prep¿ was confirmed since a separated condition was found on the body of the unit.The flared condition and elongations found on the body/shaft material as well as the ductile dimples and cup and cone-like shape 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 yield strength prior to the separation.Storage, procedural or handling factors which placed excessive tension on the catheter may have contributed to this issue.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ based on the information available, product analysis, and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH F5 INF PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12451499
• MDR Text Key: 270823706
• Report Number: 9616099-2021-04853
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032013918
• UDI-Public: (01)10705032013918(17)230430(10)17948892
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 534550S
• Device Catalogue Number: 534550S
• Device Lot Number: 17948892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• 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