MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that a fine crack was observed in an ultrathane mac-loc locking loop multipurpose drainage catheter.The patient is reportedly "ok." additional information regarding event and patient details has been requested, but is currently unavailable.

Event Description

Additional information was provided on 03aug2021.The operator placed the device in a liquid abscess for spleen abscess drainage via ct controlled seldinger technique.Aspiration was conducted to confirm positioning, however only air was returned.The device was removed and replaced with a similar device to complete the procedure successfully.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 unknown, unchanged, or unavailable.A2 - age: patient born in 1963.E1 - customer (person): phone: (b)(6).Additional information: a2, a3, b5, b7, d9, e1, e3, e4, h3, h6 - health effect - impact code and medical device problem code.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.

Manufacturer Narrative

Investigation ¿ evaluation: cook received a complaint from (b)(6) in germany reporting that the hub of a ult10.2-38-25-p-6s-clm-rh (ultrathane mac-loc locking loop multipurpose drainage catheter, lot 14007157) was cracked during a procedure.The physician placed the device and wanted to carry out a position check by aspirating through the catheter, and only air was returned.The pigtail was positioned directly in the abscess.An exchange for a new drainage system was made, and the procedure was completed successfully.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection of the returned product, were conducted during the investigation.The catheter was returned in a used and damaged condition.A visual examination of the mac-loc adaptor confirmed a fracture (crack) was present near the proximal end.The customer has also provided a photo showing the reported failure.Additionally, a document based investigation evaluation was performed.Based on the review of current documentation, cook has concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The design history file contains controls related to the reported failure.The ifu supplied (t_multi_rev 5) with the mac-loc drainage catheters instruct that the product should be inspected prior to use 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 and related subassembly found no relevant nonconformances.This device is 100% inspected for this failure in process.There are no additional complaints on the reported lot.There is no evidence of manufacturing deficiency.There is no evidence of nonconforming material in house or in the field.Based on the information provided, the examination of returned product, the results of the investigation, and since there is no evidence of design or manufacturing deficiency, the cause was traced to a component failure.The appropriate internal personnel have been notified.Per the 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.

Event Description

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

• Brand Name: ULTRATHANE 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: 12264219
• MDR Text Key: 264743539
• Report Number: 1820334-2021-01909
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)240604(10)14007157
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 14007157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1