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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/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 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, and the operator had to back the product out, 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, and the customer reported that no patient adverse events occurred as a result of the issue.The device has been returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The device was returned and the complaint has been confirmed per product examination.Device failure analysis was conducted and the stiffening cannula was measured and found to be within specifications.However, the examination verified that the catheter is too long.The cause has been determined to be manufacturer related.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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.

• 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: 7287002
• Report Number: 1820334-2018-00495
• Device Sequence Number: 1890350
• Product Code: GBO
• UDI-Device Identifier: 00827002515949
• UDI-Public: (01)00827002515949(17)200928(10)8255550
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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: ULT6.3-35-15-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/18/2018
• Patient Sequence Number: 1