MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported when the physician attempted to withdraw the device from the patient's body, it was difficult to withdraw the catheter due to adhesion of suture of the catheter and body tissue.The physician was able to withdraw the catheter, however the suture got separated and remained in the patient's body.No additional information regarding patient outcome has been provided at this time.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "while stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.Pry upward until the locking cam lever is free." the visual inspection of the returned device reported one(1) used ultrathane multipurpose drainage set, rpn cldm-8.5-mh was returned for evaluation.The catheter was curled and covered with dried blood and tissue.The suture appeared separated from the distal end of the catheter and was wrapped around the catheter about five inches from the tip.Although the device was returned for evaluation, we are unable to determine the root cause of the customer¿s reported observations, however if the pigtail was not locked in a fully closed position during the procedure this may leave a segment of the locking suture exposed in the tissue.This exposed suture may develop encrustation making it difficult to release the pigtail.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported when the physician attempted to withdraw the device from the patient's body, it was difficult to withdraw the catheter due to adhesion of suture of the catheter and body tissue.The physician was able to withdraw the catheter, however the suture got separated and remained in the patient's body.At a later date, the surgical operation was conducted again and the suture was removed with a snare.

• Brand Name: ULTRATHANE MULTIPURPOSE DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5837335
• Report Number: 1820334-2016-00749
• Device Sequence Number: 370376
• Product Code: GBO
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)190517(10)6923382
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CLDM-8.5-MH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2016
• Supplement Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention