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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 female patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for replacement of a previous ileal conduit drainage catheter.After loading the flexible stiffener into the catheter and multiple saline flushes, the operator reported difficulty ¿advancing the catheter off the stiffener during deployment.¿ it would not ¿track over the dilator properly.¿ the procedure was completed with a new, similar device successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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
Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 14jan2020.Investigation-evaluation.It was reported to cook that the flexible stiffener within a ultrathane mac-loc locking loop multipurpose drainage catheter, could not be removed from the catheter.This incident was reported by (b)(6), in the (b)(6).The device was removed, and another was placed to successfully complete the procedure.No adverse effects were reported.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, functional test, and dimensional verification, were conducted during the investigation.The complainant returned one used catheter and flexible stiffener, and one unused catheter and flexible stiffener to cook for investigation.Approximately 1 cm of the used blue flexible stiffener was noted inserted.Biomatter was noted on the distal end of the catheter.The flexible stiffener was advanced into the catheter and locked without difficulty, and then able to be removed and reinserted without difficulty.The unused stiffener was able to be inserted, advanced, and removed without difficulty, and no damage to any of the unused components was noted.All dimensions deemed relevant to the failure mode were analyzed (catheter tubing id, flexible stiffener od) and determined that the devices were manufactured within 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 final lot, one tubing subassembly lot, and one flexible stiffener raw material lot revealed no nonconformances.A database search for complaints on the reported lot found one additional complaint from the field.As both devices were confirmed to be manufactured within specification, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ based in the information provided, inspection of the returned product, and the results of the investigation cook concluded that a component failure without a manufacturing or design defect 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: 9535649
• Report Number: 1820334-2019-03166
• Device Sequence Number: 3388971
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)220826(10)9971737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 08/26/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-45-P-6S-CLM-RH
• Device Lot Number: 9971737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1