MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Abscess (1690)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Pma / 510k status: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The international customer reported that, eight days following the placement of the ultrathane mac-loc locking loop biliary drainage catheter, an abscess was discovered to have developed "at the orifice with evidence of 'plastic' debris (disintegration of the coating?) evacuating spontaneously through the orifice" [sic].The customer further reported: "there was an abscess on the side hole zone, the customer has identified plastic piece which went out of the catheter through the side holes" [sic].During a surgical procedure the surgeon removed a piece of the drainage catheter.The patient was reported to be all right after the procedure.Fragments of the device were kept for evaluation, and the return of the product is expected but has not been received at this time.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the dimensional verification, complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.Clinical assessment: the ult8.5-38-40-p-32s-clb-rh is used for percutaneous drainage in a variety of drainage applications (e.G., nephrostomy, biliary, and abscess), either by direct stick or seldinger access technique.There is no lot number available and it is not certain if the device exceeded the expiration date.The confusion is that the customer states it could be the coating but this device is coated with hydrophilic coating which would not be plastic.If the pieces are actually plastic then, it might be pieces of the catheter breaking off but this is not clear.There are no photos for review.Portions of the device are expected to be returned for evaluation.If indeed the hydrophilic coating is coming off then there is a risk of local inflammatory process that could result in ¿minor harm ¿ harm requiring medical intervention.¿ if the actual device is splintering then this could result in tissue reaction or infection and result in moderate harm - harm resulting in in-patient hospitalization or prolonged hospitalization (minor).¿ at this time there is too little information and the clinical assessment cannot eliminate any possible causes for this event such as medical procedure, placement technique, device placement, human anatomy/physiology, compatibility of other devices used, catheter maintenance, patient environment, device failure, or manufacturing related causes.One unidentifiable, cylindrical object was returned having been removed from an abscess.The object was dirty, brown in color, and appeared to either be peeling or have tape wrapped around it.The object easily broke into multiple pieces during handling.The outer diameter of one piece measured to be 0.049".The dimensions of the piece did not match the specifications of the wclt tubing, thus we are not able to confirm that the returned object is a piece of the complaint device.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We have notified the appropriate personnel and 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.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.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.Clinical assessment: the ult8.5-38-40-p-32s-clb-rh is used for percutaneous drainage in a variety of drainage applications (e.G., nephrostomy, biliary, and abscess), either by direct stick or seldinger access technique.There is no lot number available and it is not certain if the device exceeded the expiration date.The confusion is that the customer states it could be the coating but this device is coated with hydrophilic coating which would not be plastic.If the pieces are actually plastic then, it might be pieces of the catheter breaking off but this is not clear.There are no photos for review.Portions of the device are expected to be returned for evaluation.If indeed the hydrophilic coating is coming off then there is a risk of local inflammatory process that could result in ¿minor harm ¿ harm requiring medical intervention.¿ if the actual device is splintering then this could result in tissue reaction or infection and result in moderate harm - harm resulting in in-patient hospitalization or prolonged hospitalization (minor).¿ at this time there is too little information and the clinical assessment cannot eliminate any possible causes for this event such as medical procedure, placement technique, device placement, human anatomy/physiology, compatibility of other devices used, catheter maintenance, patient environment, device failure, or manufacturing related causes.One unidentifiable, cylindrical object was returned having been removed from an abscess.The object was dirty, brown in color, and appeared to either be peeling or have tape wrapped around it.The object easily broke into multiple pieces during handling.The outer diameter of one piece measured to be 0.049".The dimensions of the piece did not match the specifications of the wclt tubing, thus we are not able to confirm that the returned object is a piece of the complaint device.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We have notified the appropriate personnel and 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.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 BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7246355
• MDR Text Key: 99182661
• Report Number: 1820334-2018-00010
• Device Sequence Number: 1
• Product Code: GCA
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other