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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing placement of a thal-quick abscess drainage catheter.The customer reported that the wire guide frayed while attempting to advance the wire guide into the patient.The clinician was able to removed the wire guide without injury to the patient.There are no reported adverse patient consequences.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Per the instructions for use: "advance the "j" portion of the wire guide through the needle and into the abscess cavity.Remove the needle, leaving the wire guide in place.While maintaining the wire guide position, dilate the tract and opening into the abscess cavity by advancing the dilators in sequence (small to large) over the wire guide.To facilitate introduction, rotate the dilators during insertion.Note: it is important to advance each dilator into the abscess cavity, maintaining the position of the wire guide." based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6665803
• Report Number: 1820334-2017-01397
• Device Sequence Number: 46594
• Product Code: GBX
• UDI-Device Identifier: 00827002084544
• UDI-Public: (01)00827002084544(17)200403(10)7743970
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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 Model Number: N/A
• Device Catalogue Number: TQAS-1400-J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68