MAUDE Adverse Event Report: CORDIS US CORP. INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 534642T

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

As reported, a 6f infiniti 100cm multipurpose 2 side holes (mpa2sh) diagnostic catheter was found to be fractured in the preoperative preparation of the angiography catheter, which was removed and straighten and prepared for use.The device is expected to be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a 6f infiniti 100cm multipurpose 2 side holes (mpa2sh) diagnostic catheter was found to be fractured in the preoperative preparation of the angiography catheter, which was removed, straightened, and prepared for use.A non-sterile unit of cath f6inf tl mp a2 100cm 2sh was received for analysis.During visual inspection, the catheter was noted to be separated approximately 8.9 cm from the distal tip.Scanning electron microscopy (sem) analysis was performed and presented evidence of elongations and stretch marks.The reported ¿catheter (body/shaft) - separated¿ was confirmed.The elongations and stretch marks found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the component was induced to a tensile force that exceeded the material yield strength prior to the separation.The exact cause of the separation cannot be determined however, handling factors during preparation of the device 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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.Corrected data: previous device code 1135 (crack) was removed and updated by code 2907 (detachment of device or device component).

Manufacturer Narrative

As reported, a 6f infiniti 100cm multipurpose 2 side holes (mpa2sh) diagnostic catheter was found to be fractured in the preoperative preparation of the angiography catheter, which was removed, straightened, and prepared for use.The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)-cracked¿ 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 if package is open or damaged.Do not resterilize.Exposure to temperatures above 54o c (130o f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

Event Description

Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation.

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18584056
• MDR Text Key: 334373960
• Report Number: 9616099-2024-00032
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: 10705032014304
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534642T
• Device Lot Number: 18219125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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