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

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: lead tech.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 an unknown patient required a thal-quick abscess drainage set for an unknown procedure.During the procedure, it was noted that the distal tip of the obturator had a slit, which resulted in the shearing of the amplatz wire.This occurred with two devices of the same lot.Additional information regarding the event and patient outcome has been requested but is currently unknown.
Additional Manufacturer Narrative
Correction: upon receiving additional information from the customer regarding the failure mode, this event is not reportable.It was previously thought the wire guides that sheared were the cook wire guides provided in the set, but the customer confirmed the wire guides used were not those provided in the set.Additionally, the customer returned only two split dilators.No wire guides were returned.Therefore, it cannot be confirmed that the wire guides in this event are cook wire guides.A review of risk documentation does not indicate that the failure "split dilator" is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.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 or Problem Description
Additional information from the customer indicates the procedure was a drain change over the wire in an abdominal abscess.No adverse effects or portions of the device remained in the patient.Additionally, the wire used was not a wire included in the set.The customer only returned two split dilators, no wire guide was received.

• Brand Name: THAL-QUICK ABSCESS DRAINAGE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11362001
• Report Number: 1820334-2021-00375
• Device Sequence Number: 4170482
• Product Code: GBX
• UDI-Device Identifier: 00827002063488
• UDI-Public: (01)00827002063488(17)231124(10)13532948
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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 Expiration Date: 11/24/2023
• Device Model Number: N/A
• Device Catalogue Number: TQAS-2400-J
• Device Lot Number: 13532948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1