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

Model Number	N/A
Medical Device Problem Codes	Obstruction of Flow (2423); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 an abscess located in the left retroperitoneum.Dilation was performed prior to catheter placement and computed tomography (ct) visual guidance was utilized during the procedure.The device was placed successfully and drainage was established.On (b)(6) 2022 the catheter was removed and replaced with a larger catheter due to the thickness of the fluid.No adverse events were reported prior to the patient's exit from the study.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a.Investigation ¿ evaluation.It was reported by baylor university medical center (usa) that a thal-quick abscess drainage set (rpn: tqas-2000-j; lot#: 14097983) did not drain well.The device was required for a study procedure (mdr-1919) and was placed on 22dec2021 for an abscess located in the left retroperitoneum.Dilation was performed prior to catheter placement and computed tomography (ct) visual guidance was utilized during the procedure.The device was placed successfully, and drainage was established.On (b)(6) 2022, due to the thickness of the fluid, the patient required surgical intervention to remove and replace the catheter with a larger device to prevent permanent impairment.No other adverse events were reported prior to the patient's exit from the study.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14097983 and related subassembly lots found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.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: warnings: ¿if a catheter has become mispositioned or if drainage ceases, the catheter should be promptly exchanged or removed.¿ precautions: ¿catheters should be irrigated on a routine basis to ensure function.Patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.¿ instructions for use: ¿13.Contrast may be injected under fluoroscopic visualization to verify positioning within abscess cavity.Note: it is important that all sideports of the drainage catheter are positioned within the abscess; the most proximal sideport 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 saline may be irrigated through the small catheter and drainage collected through the large one.¿ the information gathered from the review of the 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.Based on the information provided, no returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It is possible that the catheter was not irrigated routinely enough to ensure full function.It is also possible that patient anatomy and/or condition contributed to the event.However, these possibilities cannot be confirmed without additional information.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: THAL-QUICK ABSCESS DRAINAGE SET
• Common Device Name: 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: 14959651
• Report Number: 1820334-2022-01180
• Device Sequence Number: 5497669
• Product Code: GBX
• UDI-Device Identifier: 00827002063457
• UDI-Public: (01)00827002063457(17)240930(10)14097983
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: TQAS-2000-J
• Device Lot Number: 14097983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 03/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 63 KG