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

Catalog Number	C-TQTS-800
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported four thal-quick chest tube sets were used on one patient during a thoracentesis.This report identifies the first device used.The first device (medwatch 1820334-2018-01654) was inserted and the doctor observed coiling of the wire and catheter.The device was removed and found to be frayed/damaged.A second device (medwatch 1820334-2018-01721) from the same lot was inserted and drainage began.The doctor observed an intra-pleural loop/kink and at a certain point the drainage stopped.Liquid was still present inside the cavity, therefore, the device was removed.A different doctor opened a third device for insertion and when trying to remove the wire guide, encountered resistance.The device was very difficult to remove and both the wire guide and catheter were removed.The same doctor used a fourth and final device to complete the procedure successfully.Three of the four reported devices were discarded.One device, it is unknown which failure it will present, will be returned for investigation.To date, additional patient, event and device information has been requested but not provided.As reported, the patient did not experience any adverse effects or require additional procedures due to these occurrences.
Event or Problem Description
Refer to investigation findings.
Additional Manufacturer Narrative
Investigation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned for evaluation, however, it is unknown which reported failure this device presented during use.The associated medwatch report is 1820334-2018-01721.The device was received with the stiffener in the chest tube and the wire guide within the stiffener.The wire guide was unraveled and the safety wire had broken from the distal weld.The distal curled end was still within the stiffener.The chest tube had a slight bend, however, no occlusions were found.All measurements taken during the evaluation verified the device was within specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 7581637
• Report Number: 1820334-2018-01654
• Device Sequence Number: 16773023
• Product Code: GBX
• UDI-Device Identifier: 00827002067868
• UDI-Public: (01)00827002067868(17)210320(10)8677588
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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-800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1