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

Model Number N/A

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

It was reported that a thal-quick abscess drainage set did not drain well.The device was required for a study procedure (mdr-1919) and was placed on (b)(6) 2021 for abscess drainage of a left pleural effusion.Dilation was performed prior to placement of the catheter and fluoroscopy and ultrasound guided the procedure.The catheter was placed successfully and drainage was established.However, complete fluid evacuation was not achieved with this device as the "loculated fluid" did not drain well.The catheter was removed on (b)(6) 2021 and a video assisted thoracoscopic surgery (vats) was required for drainage.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by (b)(6) medical center (usa) that a patient experienced insufficient drainage related to a thal-quick abscess drainage set (rpn: tqas-1200-j; lot#: 13919906).The device was required for a study procedure (mdr-1919) and was placed on (b)(6) 2021 for abscess drainage of a left pleural effusion.Dilation was performed prior to placement of the catheter and fluoroscopy and ultrasound guided the procedure.The catheter was placed successfully, and drainage was established; however, complete fluid evacuation was not achieved with this device as the "loculated fluid" did not drain well.The catheter was removed on (b)(6) 2021.The patient then required a video assisted thoracoscopic surgery (vats) for drainage to prevent permanent impairment or death.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record for lot 13919906 and records no non-conformances.The sub assembly lots (ni13919905 and sa13924212, sa13471702) were reviewed and found one relevant non-conformance.The nonconformance was for side ports incorrect and was scrapped per cook procedures.A database search for complaints on the reported lot found no additional complaints reported from the field.The information provided upon review of dmr, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [t_tqas_rev9] ¿thal-quick abscess drainage sets,¿ provides the following information to the user related to the reported failure mode: precautions: ¿catheters should be irrigated on a routine basis to ensure function.Patient with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.¿ instructions for use: ¿contrast may be injected under fluoroscopic visualization to verify positioning within abscess cavity.Note: it is important that all side ports of the drainage catheter are positioned within the abscess; the most proximal side port forms a break in the solid radiopaque stripe.In some large abscess cavities, it may be useful to insert two catheters, one small and one large, so that the saline may be irrigated through the small catheter and drainage collected through the large one.¿ based on the information provided, no returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the catheter wasn¿t irrigated routinely enough to ensure full function, but cook is unable to confirm this.It is also possible that patient anatomy and/or condition contributed to this event; however, these possibilities cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

Event Description

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

• Brand Name: THAL-QUICK ABSCESS DRAINAGE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14959570
• MDR Text Key: 295599787
• Report Number: 1820334-2022-01178
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002063365
• UDI-Public: (01)00827002063365(17)240809(10)13919906
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TQAS-1200-J
• Device Lot Number: 13919906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG