MAUDE Adverse Event Report: COVIDIEN FOLY CATH 100 SLCON 3CC 8FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number 8887603085

Device Problem Deflation Problem (1149)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the catheter's balloon would not deflate when it was ready to be removed.The patient had to be taken to surgery to have it removed.Additional information provided on 17-aug-2020 stated that the five year old female who recently underwent resection of a large left malignant renal tumor where at that time she had an epidural placed as well as a foley catheter on (b)(6) 2020.The catheter was not tested prior to insertion.The patient met criteria for removing the foley catheter three days later.However, both the nurses and the surgical resident were unable to deflate the balloon to extract the catheter.For that reason, the md was called to the beside and attempted to remove the catheter by aspirating air and/or fluid from the balloon but was unsuccessful.Next, they cut the catheter in hopes that this would allow the balloon to deflate.However this too did not work.Additional attempts at passing a wire down the insufflation channel in hopes of removing any debris to allow the balloon to deflate were unsuccessful.Also, injecting through the inflation port in hopes of clearing obstruction allowing it to drain were unsuccessful.For that reason, the child was taken to the operating room for cystoscopy and lysis of the balloon to allow the hcp to extract the foley catheter.Operative permit was obtained from the mother.The child was taken to the operating room and placed on the or table in the supine position.After an adequate level of general inhalational anesthesia was administered, she was positioned at the foot of the bed with the legs in stirrups in a modified lithotomy position.The peritoneum was prepped and draped in usual sterile fashion.A timeout was conducted confirming the correct patient and the correct procedure.Pediatric rigid cystoscope was introduced through the urethra into the bladder.The inflated balloon was identified along with the catheter.Endoscopic grasping forceps were placed through the working channel of the port and the catheter proximal to the balloon was grasped advancing the balloon towards the urethra opening.Multiple attempts at grasping with the balloon with the grasper were unsuccessful, therefore using a tip of a fine nonlaparoscopic grasping forceps, the md was able to place along the cystoscope until they could rupture the balloon.This was done without difficulty and the foley catheter remnant removed with the balloon materials intact.The scope was reintroduced again looking for any remnant and there was one, therefore, the scope was removed.The patient tolerated the procedure well.It should be noted the bladder was drained of all fluid at the end of the procedure.The child was then awakened and transported to the post anesthetic care unit in good condition.

• Brand Name: FOLY CATH 100 SLCON 3CC 8FR
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10474203
• MDR Text Key: 205138861
• Report Number: 1282497-2020-09392
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 10884521016606
• UDI-Public: 10884521016606
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8887603085
• Device Catalogue Number: 8887603085
• Device Lot Number: 2005915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 179