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

Catalog Number 534550S

Device Problem Partial Blockage (1065)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

A product history record (phr) review of lot 18155305 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.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.

Event Description

As reported, after catheter flushing and review, the staff recorded that a 5f 110cm 6 side holes (6sh) infiniti diagnostic pigtail catheter did not contain the side holes as usual.The catheter was not introduced in the patient and was marked as a claim/adverse event.The intended procedure was reported to be a percutaneous coronary intervention (pci) catheterization.Another unknown diagnostic catheter was used to complete the procedure.There was no reported patient injury.The medical staff took the procedure as per the instruction for use (ifu).On the preparing table the device was flushed with cold saline during handling in accordance with the ifu and the device did not contain side holes.The product was stored according to the ifu.The packaging of the medical device was without any defect and the sterile packaging was without any damage.Before introducing it to the patient, visual control of the infiniti catheter was performed.The complaint device is expected to be returned for evaluation.The event was reported by the hospital to the local competent authority (ca) as an adverse event.Device pictures were received for review.

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.

Manufacturer Narrative

As reported, after catheter flushing and review, the staff recorded that a 5f 110cm 6 side holes (6sh) infiniti diagnostic pigtail catheter did not contain the side holes as usual.The catheter was not introduced in the patient and was marked as a claim/adverse event.The intended procedure was reported to be a percutaneous coronary intervention (pci) catheterization.Another unknown diagnostic catheter was used to complete the procedure.There was no reported patient injury.The medical staff took the procedure as per the instruction for use (ifu).On the preparing table the device was flushed with cold saline during handling in accordance with the ifu and the device did not contain side holes.The product was stored according to the ifu.The packaging of the medical device was without any defect and the sterile packaging was without any damage.Before introducing it to the patient, visual control of the infiniti catheter was performed.One non-sterile unit of cath f5 inf pig 110cm 6sh was received for analysis.Per visual inspection, the side holes on the catheter were missing.A product history record (phr) review of lot 18155305 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft)- no side holes-pigtail catheter¿ was confirmed.The pigtail catheter does not contain side holes.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, ¿¿¿manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Do not use if the package is open or damaged.¿ per analysis of the returned device, the missing side holes was found to be manufacturing related and a risk assessment was initiated to address this issue.

• 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 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17926535
• MDR Text Key: 325872099
• Report Number: 9616099-2023-06609
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032013918
• UDI-Public: 10705032013918
• 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
• Report Date: 12/04/2023

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 Catalogue Number: 534550S
• Device Lot Number: 18155305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 12/01/2023
• Supplement Dates FDA Received: 11/01/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2022
• 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
• Treatment: NOT AVAILABLE.