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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Occupation: risk management specialist.Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.(b)(4).
Event or Problem Description
Hhs/fda form 3500a has been received by cinc on 28-jan-2019.It was reported an ultrathane mac-loc locking loop multipurpose drainage catheter was used for an unknown procedure.While trying to remove the flexible stiffener during the procedure, it became stuck in the catheter and caused the catheter to accordion.The catheter was removed with the stiffener and a new drain was used to complete the procedure.Three reports with the same failure mode have been created to capture mdr's #1820334-2018-03802, 1820334-2019-00275 which is the subject of this report.Additional information regarding these events has been requested, however response from the facility risk manager informed the manufacturer that, ¿i was not able to obtain additional information from the lead or supervisor¿.¿.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
The complaint device was not returned for evaluation.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, trends, and documentation of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a similar product failure was investigated and recorded in medwatch report #1820334-2018-03752.This investigation noted heavy deformation of the stiffener but was inconclusive.However, 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 one related nonconforming event in which the device was scrapped.It should be noted there is one other reported complaint for this lot number.Based on the information provided, no returned product, and the results of the investigation, a definitive root cause could not be determined.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor 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 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: 8336929
• Report Number: 1820334-2019-00276
• Device Sequence Number: 1554846
• Product Code: GBO
• UDI-Device Identifier: 00827002289161
• UDI-Public: (01)00827002289161(17)210815(10)9095634
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/05/2019

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: 08/15/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-60-P-6S-CLM-RH
• Device Lot Number: 9095634
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1