MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number C-PCS-700-TORONTO-042997

Device Problem Failure to Advance (2524)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.

Event Description

It was reported that the device was used for pericardial drainage and the physician was unable to advance the catheter over the wire guide.However, the physician removed the catheter and wire together as a unit since there was inability to advance the catheter.The wire guide was replaced with another manufacturer's wire guide, then the same catheter could advance over the replacement and could be placed for drainage successfully.It was further noted that the complaint wire guide was elongated and the user may have tried to remove the catheter while the wire guide remained in the patient.There were no reported adverse effects to the patient as a result of the product problem.

• Brand Name: PERICARDIOCENTESIS CATHETER SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7378149
• MDR Text Key: 104036896
• Report Number: 1820334-2018-00895
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002106437
• UDI-Public: (01)00827002106437(17)190103(10)6420612
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-PCS-700-TORONTO-042997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2016
• 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