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 Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2020

Event Type  malfunction  

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 Description

It was reported a (b)(6) year old female patient required a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for a pericardial drainage procedure.During the procedure, the user attempted to place the catheter via trocar access however, the catheter would not advance into the skin.The operator stated that the needle successfully punctured the skin, but the catheter began to bend and would not advance.A similar device was placed using seldinger technique to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.D10 ¿ product received on: 21oct2020.Investigation ¿ evaluation.(b)(6) med.Equip.In china informed cook that on 11sep2020, an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter would not advance into the patient's body during a pericardial drainage procedure.The user activated the hydrophilic coating and assembled the device for trocar access.The trocar needle punctured the skin, but the catheter would not advance and started bending.A 7.0fr drainage catheter was used instead and was successfully placed via seldinger technique over a wire guide.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The customer returned one used ult5.0 catheter with the metal stiffening cannula and trocar assembly inserted.The cannula/trocar assembly is bent at the proximal end.There is no additional damage.The catheter taper, outer diameter, and distances from the trocar to catheter tip and cannula tip all measure within specification.Additionally, a document based investigation evaluation was performed.There are appropriate controls in place to address the reported failure.The device is shipped with instruction for use (ifu) which provides the following information to the user 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." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot has a failure-related nonconformance for tip/taper inadequate.All nonconforming devices were scrapped.The returned device showed that the taper is within specification, therefore, this nonconformance is not related to this complaint.The relevant catheter and tubing subassembly lots did not have related nonconformances.There are no additional complaints on the lot.Therefore, there is no evidence of nonconforming material in house or in the field.The returned device measured within specification.The user changed from a 5.0fr catheter and trocar technique to a 7.0fr catheter and seldinger technique.A 7.0fr catheter would offer more support than the 5.0fr and seldinger technique likely allowed for easier access.Based on the information provided, examination of the returned product, and the results of the investigation, the most likely cause of the failure is procedure-related.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.

Event Description

No additional information regarding the patient and/or event 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: 10548001
• MDR Text Key: 207373934
• Report Number: 1820334-2020-01705
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002110182
• UDI-Public: (01)00827002110182(17)230325(10)NS13082759
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT5.0-18-25-P-5S-CLDM-HC
• Device Lot Number: NS13082759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 44