MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE SET; GBX CATHETER, IRRIGATION

Catalog Number C-TQTS-1800

Device Problems Difficult to Remove (1528); Physical Property Issue (3008)

Patient Problem Pain (1994)

Event Date 03/01/2015

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.

Event Description

It was reported that after placing the drainage catheter (left pleura), the physician tried to remove the wire guide.However, difficulty was encountered.The physician exerted more force on the wire guide until it began coming out of the patient¿s chest.It was noted the wire guide exhibited coil elongation.A second drainage catheter was used to complete the procedure.The physician noted that the accompanying wire guide of the second drainage catheter (unknown lot) also exhibited coil elongation in the same location after the physician examined it and exerted force on it following the placement of the second drainage catheter.According to the initial reporter, the patient suffered additional pain caused by the new drainage catheter which was placed.

• Brand Name: THAL-QUICK CHEST TUBE 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: 6792309
• MDR Text Key: 82958730
• Report Number: 1820334-2017-02472
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002054530
• UDI-Public: (01)00827002054530(17)150601(10)3484372
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

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: C-TQTS-1800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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
• Patient Age: 85 YR
• Patient Weight: 60