MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 538450S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: during an unknown procedure, when advancing the guidewire into a 4f infiniti (110cm 6sh) pigtail catheter, the pigtail end broke off.There was no reported patient injury.Multiple attempts to gather additional information were unsuccessful.The device was not returned for analysis.A product history record (phr) review of lot 17581813 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 ¿ brite tip/distal tip ¿ catheters separated¿ could not be confirmed as the device was not returned for analysis and procedural films/device photographs were not received.It is difficult to draw a clinical conclusion between the device and the event based on the limited information available.However, procedural and handling factors may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation, ¿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.¿ neither the phr review nor the available information suggest that the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, when advancing the guidewire into a 4f infiniti (110cm 6sh) pigtail catheter, the pigtail end broke off.There was no reported patient injury.

• Brand Name: CATH F4 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8421456
• MDR Text Key: 138830799
• Report Number: 9616099-2019-02781
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032014820
• UDI-Public: 20705032014820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2019

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: 08/31/2019
• Device Model Number: 538450S
• Device Catalogue Number: 538450S
• Device Lot Number: 17581813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2016
• 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