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 08/03/2020

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 catheter was not tested prior to insertion.The information further stated that the (b)(6) month old patient had a foley catheter passed during a complex left tapered ureteral reimplantation on (b)(6) 2020.The patient arrived to the surgeon's office on (b)(6) 2020 after the family was attempting to remove the foley at the primary care physician and the foley would not easily be removed.At the surgeon's office attempts at trying to aspirate the balloon were unsuccessful, they even cut the port to see if this would relieve some fluid from the balloon and this was unsuccessful.Risks, benefits and options for cystoscopy, possible percutaneous attempts at removing the retained foley were discussed with the family at length and they agreed to proceed.The patient was taken to the operating room, after adequate general anesthesia placed in the supine lithotomy position.The area was prepped and draped in normal sterile fashion.A very small dental wire was passed down the balloon port of the 8fr foley to see if this would puncture the balloon or relieve any debris and this was unsuccessful on multiple attempts.A suprapubic very fine needle was inserted diagonally 45° towards the bladder neck to see if this could puncture the balloon and this was also unsuccessful.They were able to finally get the neonatal small cystoscope along side the foley catheter up into the bladder neck and they could see the balloon.Eventually after several attempts at passing a needle the md would then remove the scope itself and left the opturator in place and with the foley catheter on tension the md was able to pass a dental wire and puncture the balloon through the cystoscopic sheath.The catheter and the stent that was attached to it was then easily removed.There was no obvious complications encountered.A rectal exam was performed which revealed no obvious blood or any abnormalities.The patient did receive broad-spectrum antibiotics.The patient was awakened and transferred to the recovery room in satisfactory 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: 10474328
• MDR Text Key: 205263015
• Report Number: 1282497-2020-09393
• 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: 2011813
• 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: 10 MO
• Patient Weight: 8