MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event was reported to have occurred in (b)(6) of 2017, exact date is unknown at this time.The 510k status: exempt.(b)(4).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
The customer reported that, during a gastro-jejunal tube insertion procedure, the soft stiffener of the ultrathane mac-loc locking loop multipurpose drainage catheter became stuck in the catheter portion of the device, and the radiologist was initially unable to remove it post-insertion.However, the device eventually could be removed.Upon removal, it was noted that the stiffener appeared to have buckled.A repeat drainage tube insertion was performed once the complaint device was removed.The device was received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, drawings, instructions for use (ifu), specifications, quality control data, dimensional verification, and visual inspection of the returned device was conducted during the investigation.One used device was returned with biomatter present.The stiffener was not inserted in the catheter, and it appeared that both had been cut in order to remove from the patient.The inner diameter of the catheter and outer diameter of the stiffener both measured within specification.The failure could not be duplicated.The manufacturing documents in place at the time of manufacture were reviewed and no notable gaps in production or processing controls were noted.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.The subassembly device history record was also reviewed and non-conformances were noted; however, all non-conforming product was scrapped prior to completion of the final lot.A review of our complaint records confirmed this was the only complaint related to this lot number.Based on the provided information, inspection of the returned device, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7216760
• Report Number: 1820334-2018-00052
• Device Sequence Number: 1146027
• Product Code: GBO
• UDI-Device Identifier: 00827002096417
• UDI-Public: (01)00827002096417(17)200323(10)7773068
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: ULT12.0-38-60-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1