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 Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Reported to a regulatory agency: unknown.Pma/510(k) #: preamendment.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 ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was deployed during a ptcd procedure.After the treatment of obstructive jaundice, the user attempted to remove the complaint device, but the hub became separated from the catheter body.The complaint device was then removed from the patient successfully.No adverse effects to the patient were reported in connection with this event.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.D10 ¿ product received on- 16apr2019.Investigation ¿ evaluation.A review of the complaint history, device history record, and documentation, as well as a dimensional verification and visual inspection, were conducted during the investigation.The complaint device was returned in a used and damaged condition.The visual inspection found the catheter separated from the hub.The flare was noted to be damaged slightly out of round.The flare cannot be confirmed to have been manufactured out of specification because the flare is compressed within the cap during manufacturing processes.The action of the flare being pulled through the cap may also have caused the flare to become out of round.All relevant and undamaged device dimensions were measured to be within specification.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9181676 showed no related nonconformances.Review of related subassembly lots showed no related nonconformances.A software search revealed no other complaints from lot 9181676 at the time of investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, visual inspection of the returned device and the results of the investigation, a definitive cause could not be established appropriate measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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

Additional information was received on (b)(6) 2019.No resistance was felt during placement of the catheter.The catheter was in place for nine days before removal.During removal, slight resistance was felt and the hub separated from the catheter.

Manufacturer Narrative

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

• 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: 8503103
• MDR Text Key: 142394954
• Report Number: 1820334-2019-00831
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)210921(10)9181676
• 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: 05/22/2019

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: 09/21/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 9181676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 04/16/2019; 05/14/2019
• Supplement Dates FDA Received: 04/16/2019; 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1