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

Model Number N/A

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

It was reported that the wire of a thal-quick chest tube set "tore when pulled back" during an emergency chest tube placement procedure.Photos of the device showed the wire to be elongated.During use, the wire was reported to be "not possible to pull out" and "stretched" with a "weak spot on tip".No adverse effects to the patient have been reported.Additional information regarding the event and patient has been requested but is unavailable at the time of this report.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information regarding the event was received on 28jan2020.The wire was withdrawn through the obturator.No additional procedures or use of additional equipment were necessary.

Event Description

No additional patient/event information has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation: klinikum landsberg a.Lech (germany) informed cook that the wire guide in a c-tqts-1200 (thal-quick chest tube set) from lot 7820419 unraveled during a chest drain placement on (b)(6) 2019.The customer reported that the wire separated when it was withdrawn through the chest drain obturator (stiffener).The patient did not require any procedures to retrieve the wire, and did not experience adverse effects.A review of the documentation including the complaint history, device history record (dhr), manufacturing instructions (mi) and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used and damaged wire guide was returned to cook for evaluation.Upon visual inspection, the safety wire was noted to be broken from the distal weld ball and was protruding through the coil.As a result, the wire guide was elongated from the solder connection to the distal tip.The distal weld ball is present and attached to the coiling.The solder connection appears to be intact.Evaluation of the device did not suggest that it was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that adequate inspection activities are in place to address this failure mode prior to distribution.A review of the dhr for the reported complaint device lot (7820419) revealed no recorded non-conformances.However, a review of the wire guide sub-assembly lot recorded non-conformances for a broken solder and for curve damage in which the non-conforming devices were scrapped.A database search found this to be the only event associated with the reported complaint device lot.Reviewing the design history file found that the device is both safe and effective for its intended use.As a result, cook concluded that there is no evidence that non-conforming material exists either in house or in the field.Cook also reviewed product labeling.The complaint c-tqts-1200 was shipped with the instructions for use.The ifu states: "instructions for use 5.When the appropriate drainage site has been identified, advance the soft "j" end of the wire guide though the needle nd into the pleural space.Note: the wire guide should pass through the needle and advance into the pleural space without resistance.8.While maintaining the wire guide position, dilate the tract and opening into the pleural space by advancing, in sequence small to large, the supplied dilators over the wire guide.Introduction into the pleural space is facilitated by rotating and advancing the dilators in line with the wire guide to prevent its kinking.9.With the wire guide still positioned within the pleural space, advance the chest tube inserter/chest tube assembly over the wire guide and into the pleural space.Note: if resistance is encountered during chest tube assembly insertion, determine the cause of resistance and take necessary action to relieve resistance before proceeding.Note: it is important t advance the chest tube assembly into the pleural space in the same line as the wire guide.This will make introduction easier and avoid kinking of the wire guide.10.Remove the wire guide and chest tube inserter, leaving the chest tube in place." based on the information provided, evaluation of the returned device, and the results of our investigation, a definitive root cause was traced to component failure without a design or manufacturing deficiency.The customer informed cook that the wire guide was withdrawn through the chest tube obturator (stiffener) and unraveled.It is possible that when the wire was withdrawn, the "j" curve caught on the stiffener tip and the safety wire separated from the weld ball, resulting in elongation.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9537774
• MDR Text Key: 178331300
• Report Number: 1820334-2020-00005
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002051614
• UDI-Public: (01)00827002051614(17)200412(10)7820419
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1200
• Device Lot Number: 7820419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1