MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F BER II 65CM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 451415V0

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17798728) 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, during a percutaneous nephrostomy (pcn) tube placement (pcn) exchange, two 4f tempo diagnostic catheters were used and the guide wire penetrated through.There was no reported patient injury.The devices will be return for evaluation.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

After further review of additional information received the following: date rec¿d by mfr and if follow-up, what type have been updated accordingly.During a percutaneous nephrostomy tube exchange, two 4f tempo diagnostic catheters were used and the guide wire penetrated through.There was no reported patient injury.Additional information was requested but no response was provided.No additional information is available.The devices were not returned for analysis.A product history record (phr) review of lot: 17798728 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter (body/shaft) puncture/cut - in-patient¿ events were confirmed in both devices via the device photographs that were received for analysis, however the devices were not returned for analysis.The exact cause of the puncture/cut found on the catheters could not be conclusively determined.Based on the limited information available for review, procedural and handling factors may have contributed to the events reported.According to the instructions for use, which is not intended as a mitigation, ¿discard catheters after one procedure.Structural integrity and/or function may be impaired through reuse or cleaning.Do not expose to organic solvents.Do not exceed maximum pressure rating printed on product label and hub.Store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ the phr review does not suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2018-02456.

• Brand Name: CATH TEMPO 4F BER II 65CM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8000257
• MDR Text Key: 124989775
• Report Number: 9616099-2018-02457
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 451415V0
• Device Lot Number: 17798728
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1