MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER 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)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 510k status: exempt.The device failure analysis discovered the catheter extends approximately 4 mm past the trocar/ cannula assembly.An attempt was made to remove the trocar/ cannula assembly, encountering resistance, resulting in the catheter shaft accordion.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 placement of the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter in the patient's abdomen as part of a sclerotherapy procedure, the trocar needle wasn¿t protruding out of the end as expected.A direct stick was not possible.The physician had to "hit exit out" [sic], which resulted in an inability to remove the needle from the catheter once it was in the patient.The device had to be removed, and a re-sticking of the patient was necessary.The device was reportedly only in place for a period of minutes.During the investigation difficulty removing the trocar stylet/ stiffening cannula assembly resulted in accordion of the shaft of the catheter was determined to be a separate failure mode.The customer reported that no patient adverse events occurred as a result of the issue.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification/functional testing of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the report of a lodged cannula within the catheter.Functional testing identified resistance when trying to remove the cannula in addition to the catheter wrinkling during this process.Examination also noted that the catheter extends too far past the trocar/cannula assembly.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no related nonconformances.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.This failure mode has been escalated per internal processes.We have notified the appropriate personnel and will continue to monitor for similar events.

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 7390410
• Report Number: 1820334-2018-00827
• Device Sequence Number: 11188837
• Product Code: GBO
• UDI-Device Identifier: 00827002515949
• UDI-Public: (01)00827002515949(17)201212(10)8440330
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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 Expiration Date: 12/12/2020
• Device Model Number: N/A
• Device Catalogue Number: ULT6.3-35-15-P-5S-CLDM-HC
• Device Lot Number: 8440330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 06/19/2018
• Patient Sequence Number: 1