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	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: quality engineer.Pma/510(k) #: 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
It was reported a female patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for drainage procedure.A week after placement, the mac-loc "tip of the catheter near the hub" was detached from the catheter.The catheter was removed from the patient successfully, and the physician replaced it with another new, similar device.No other adverse effects were reported for this incident.
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
D10: product received on: 09jan2020.Investigation/evaluation: it was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter experienced hub separation one week after placement.The patient tied a knot with the tubing and went back to the hospital.The physician removed the device and replace it with another catheter without losing access.Cook became aware of this event upon being notified by liaoning adsun med.Equip.Co.The patient reportedly experienced no other adverse effects as a result of this incident.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The catheter tubing of a used 7.0fr catheter was returned already separated from the hub.The hub was not returned.Biological matter was present.The section returned measured 6.7cm in length, and was tied in a knot located 4.5cm from the flare.The flare appears slightly out of round, with an indention likely from the suture.The flare may have been damaged when it was pulled through the cap.Additionally, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release.Validations are in place to address this failure mode.The instructions for use (ifu) supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots found no related nonconformances.A database search revealed no other complaints from the complaint lot at the time of investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.It is possible that the user unintentionally pulled the tubing from the hub since it was in place for a week.However, this cannot be confirmed without additional information.Based on the information provided, the examination of returned product and the results of the investigation, it was determined that a component failure unrelated to design and manufacturing deficiencies contributed to the failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: 9540111
• Report Number: 1820334-2020-00044
• Device Sequence Number: 16719264
• Product Code: GBO
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)220806(10)9931258
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 9931258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 55