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

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.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 Description

It was reported an unknown patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for bile duct drainage via abdominal approach.When the physician attempted to insert the catheter into the patient, there was significant resistance.The catheter could not be inserted, so another device was used to complete the procedure.It was also noted that the physician made additional drainage holes in the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) in japan informed cook that on (b)(6) 2021 an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from lot 13503882 was difficult to insert into the patient.The user reportedly made additional drainage holes in the catheter prior to inserting.When they advanced the catheter into the patient, they noted resistance.The device was removed, and a new device was used to complete the procedure.The patient did not experience adverse effects.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One used ult7.0 catheter and metal stiffener were returned for evaluation.The black suture string was found to be broken; however, the broken portion of the string was not returned.The dtn stiffener was advanced through the catheter with no issue.There were two additional drainage holes on the catheter shaft just above the last required drainage hole.The catheter tip was noted to be undamaged.Catheter tubing was measured and was found to be within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that appropriate controls are in place to detect this failure prior to distribution.A review of the design history file (dhf) showed that adequate risk mitigation activities are in place to capture potential failure modes prior to customer release.A review of the device history record (dhr) for lot 13503882 and related subassembly lots found no related nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints associated with this lot number.Based on the dmr, dhr, device failure analysis, and dhf review, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.The instructions for use (ifu), provides the following information related to the reported failure mode: "precautions: activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the additional drainage holes were placed proximal to the existing drainage holes, and it is possible that these additional drainage holes contributed to resistance.It is also possible that the patient¿s anatomy could have contributed to the resistance.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11349585
• MDR Text Key: 234272550
• Report Number: 1820334-2021-00358
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)231021(10)13503882
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 13503882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1