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)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: 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 an unknown patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for a stent exchange procedure.Once the stent was correctly positioned, the blue flexible stiffener was not easily removable.A device from a different lot was used to successfully complete the procedure.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: (b)(6)2020.Investigation ¿ evaluation (b)(6) in the united kingdom informed cook that on (b)(6)2020, the stiffener in an ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to remove from the catheter.The failure occurred during a catheter exchange.The user placed the catheter but had difficulty removing the flexible stiffener.Another device was used to complete the procedure successfully.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The customer returned one used ult8.5 with the blue flexible stiffener lodged in the catheter.The stiffener was removed with difficulty and is elongated on the proximal end.The catheter was cut to obtain measurements.There is no indication the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.There are appropriate inspections in place to address this failure.The device history record for the complaint lot was reviewed to check for related nonconformances and additional complaints.The complaint final and related subassembly lots were reviewed.The catheter tubing lot has related nonconformances for "i.D incorrect" where the inner diameter was too small.This is related to the reported failure.However, the returned device inner diameter measured within specification.It is not suspected that the catheter is nonconforming.Additionally, there is a 100% inspection of the fit between the catheter and stiffener.No other related nonconformances were recorded.There are no additional complaints on the lot.There is no evidence of nonconforming material in house or in the field.The product labeling was reviewed.The product ifu, ¿multipurpose drainage catheter,¿ states: "precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a capa was previously opened for this device failure.The capa implemented corrective actions related to supplier manufacturing.This lot was manufactured prior to corrective action implementation.Based on the information provided, inspection of returned product and the results of the investigation, the cause of this event is supplier manufacturing.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: 10952070
• Report Number: 1820334-2020-02247
• Device Sequence Number: 19585021
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)230409(10)13124023
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 04/09/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 13124023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1