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

Catalog Number	C-TQTS-1800
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6792309
• Report Number: 1820334-2017-02472
• Device Sequence Number: 129537
• Product Code: GBX
• UDI-Device Identifier: 00827002054530
• UDI-Public: (01)00827002054530(17)150601(10)3484372
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: C-TQTS-1800
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 60