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	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: lead tech.Pma/510(k) #: exempt.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 (b)(6) year old male required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a liver abscess drain exchange procedure.The drain was placed on (b)(6) 2020.On (b)(6) 2020, the drain was unlocked, cut, and slowly retracted with no resistance.After removal, the operator noted that the distal tip of the catheter appeared to remain in the patient.A ct scan was performed, showing an approximately 1 cm piece of the distal tip of the catheter retained in the "central portion of the old liver abscess cavity." no other adverse events were reported.
Event or Problem Description
The complaint device was received 04mar2020 confirmed the tip of the catheter, hub of the catheter, and suture were missing from the device.The catheter shaft was also separated.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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
Investigation/evaluation: it was reported to cook that the tip of the catheter within a ultrathane mac-loc locking loop multipurpose drainage catheter separated from the shaft.This incident was reported by (b)(6) hospital, in the united states.The device was removed, and the tip will be removed upon patient¿s approval.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned one section of a ult catheter to cook for investigation.A 29 cm portion of a ult catheter was returned used with the distal tip and mac-loc hub missing due to the physician cutting it off.No other damage to the device was noted, but biomatter was present.At this time, cook cannot conclude that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) was reviewed.The review for the final lot and subassembly lots revealed no relevant nonconformances.A complaint database search revealed no additional complaints reported from the field.At this time, cook could not conclude that nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi_rev5 [multipurpose drainage catheter] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: how supplied: ¿upon removal from package, inspect the device to ensure no damage has occurred.¿ based on the information provided, inspection of returned product, and results of the investigation, it was concluded a component failure without a manufacturing or design deficiency contributed to this incident.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: 9781006
• Report Number: 1820334-2020-00533
• Device Sequence Number: 559401
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)221211(10)10205320
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2020

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: 12/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Device Lot Number: 10205320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 04/27/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/11/2020; 05/05/2020
• 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: Other
• Patient Age: 34 YR
• Patient Weight: 87