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 Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: unsure.Occupation: unknown.Reported to 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 a ultrathane mac-loc locking loop multipurpose drainage catheter was used in an unknown patient for a percutaneous cholecystectomy procedure.As reported the patient was being repositioned in the bed, when hub separation was noted.The reporter is unsure if the device was pulled during repositioning.Additional information regarding the event and patient outcome has been requested but is currently unavailable.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history and documentation review were conducted during the investigation.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 could not be performed due to an unknown lot number.Review of the sales records to the user facility over the past three years could not sufficiently narrow down the lot number.Since the lot number of the device is unknown, potential nonconformances or other complaints from the complaint device¿s lot could not be confirmed.The product¿s design history file shows evidence of validations in place to meet design requirements related to this failure mode.Compiling this information, nonconforming product is not suspected in house or in the field.The complainant did not return the complaint device to cook for investigation.Since physical measurements of the complaint device could not be taken, the device cannot be confirmed to manufactured out of specification.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures are being conducted to address this failure mode.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.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 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: 8527200
• MDR Text Key: 142354198
• Report Number: 1820334-2019-00838
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 05/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention