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 Patient Involvement (2645)
Date of Event	10/20/2017
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
The customer reported that, when the ultrathane mac-loc locking loop multipurpose drainage catheter was removed from the packaging, the flexible stiffener could not be removed from the product.A competitor's catheter was opened and used to complete the procedure, with no patient adverse events reported.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, complaint history, device history record, drawing, ifu, manufacturing instructions, and quality control data was conducted during the investigation.Six unopened, unused devices from the different lot were returned for evaluation.Actual complaint device was not returned for the investigation.The outer diameter of the flexible stiffener and the inner diameter of the catheter measured within specification for all six devices.The flexible stiffener was inserted into the catheter for all six devices.Mild resistance was felt during insertion and removal; however, none of the flexible stiffeners got lodged in the catheter.The one device that the customer claimed had failed was not returned and was from a different lot.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Since none of the devices measured out of specification, the failure mode was deemed inconclusive.The exact root cause can not be determined at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the risk assessment no further action is required.

• 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: 6993199
• Report Number: 1820334-2017-03728
• Device Sequence Number: 11225253
• Product Code: GBO
• UDI-Device Identifier: 00827002096417
• UDI-Public: (01)00827002096417(17)200411(10)7820223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: No Information
• 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: 10/20/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1