MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FLUORO-4 SILICONE URETERAL COIL STENT; FLUORO-4¿ COIL SILICONE URETERAL STENT 6CH MULTILENGHT

Model Number 277406

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problems Irritation (1941); Patient Problem/Medical Problem (2688)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the fluoro-4 silicone stent was knotted on one end inside the patient.This was found due to the stents not draining properly.The urologist was able to remove the stent after careful retraction.Per additional information from the ibc via email (b)(6) 2020, the stent was removed from the patient using a cystoscopy and forceps.No additional intervention or treatment was required according to the urologist.The urologist was able to safely remove the stent, with no major injuries.However some stone fragments caught behind the knot might have caused minor irritation of the mucosa.No supplementary medication or additional treatment was required.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (no original packaging), used fluro-4 coil stent.It was noted that the stent had no knots and was generally in the intended shape it was designed, with there only being the intended coils at each end, and it was noted that of the ends that seemed to have become slightly unraveled during use.This meets the specification "coil must conform to print" per inspection procedure.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "directions for use: (open end) 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Pass the guidewire flexible tip beyond the obstruction to the renal pelvis.Note: tortuosity in the obstructed ureter can often be resolved using the guidewire and open end ureteral catheter in combination.3.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant holds the guidewire in position to prevent advancement of the wire into the renal parenchyma.4.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant removes the guidewire as the operator holds the stent in position with the push catheter.The retention coil will form spontaneously.Carefully remove the push catheter from the cystoscope.Preloaded stent with clamp 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Place guidewire into distal (bladder) end of stent.Advance guidewire to the proximal end of the stent.If stiff end of guidewire is used, do not allow guidewire tip to extend past proximal tip of stent.(this will help keep stent in place for insertion.) 3.Place push catheter on guidewire until it abuts distal end of stent.4.Place small white clamp at most distal end of push catheter and clamp securely (see fig.1).This will ensure correct positioning of stent on the push catheter during insertion procedure.5.Insert stent.6.When placement is complete, release clamp by pushing top portion back and remove from push catheter (see fig.2).7.Hold push catheter and remove guidewire.The stent retention loop will form spontaneously.Then carefully remove push catheter from cystoscope.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction using endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations." correction: d4 h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the flouro-4 silicone stent was knotted on one end inside the patient.This was found due to the stents not draining properly.The urologist was able to remove the stent after careful retraction.Per additional information from the ibc via email(b)(6)2020 , the stent was removed from the patient using a cystoscopy and forceps.No additional intervention or treatment was required according to the urologist.The urologist was able to safely remove the stent, with no major injuries.However some stone fragments caught behind the knot might have caused minor irritation of the mucosa.No supplementary medication or additional treatment was required.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging), used fluro-4 coil stent.It was noted that the stent had a knot near the round coiled end.This does not meet the specification "coil must conform to print" per inspection procedure.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be part geometry.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "directions for use: (open end) 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Pass the guidewire flexible tip beyond the obstruction to the renal pelvis.Note: tortuosity in the obstructed ureter can often be resolved using the guidewire and open end ureteral catheter in combination.3.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant holds the guidewire in position to prevent advancement of the wire into the renal parenchyma.4.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant removes the guidewire as the operator holds the stent in position with the push catheter.The retention coil will form spontaneously.Carefully remove the push catheter from the cystoscope.Preloaded stent with clamp 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Place guidewire into distal (bladder) end of stent.Advance guidewire to the proximal end of the stent.If stiff end of guidewire is used, do not allow guidewire tip to extend past proximal tip of stent.(this will help keep stent in place for insertion.) 3.Place push catheter on guidewire until it abuts distal end of stent.4.Place small white clamp at most distal end of push catheter and clamp securely (see fig.1).This will ensure correct positioning of stent on the push catheter during insertion procedure.5.Insert stent.6.When placement is complete, release clamp by pushing top portion back and remove from push catheter (see fig.2).7.Hold push catheter and remove guidewire.The stent retention loop will form spontaneously.Then carefully remove push catheter from cystoscope.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction using endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the flouro-4 silicone stent was knotted on one end inside the patient.This was found due to the stents not draining properly.The urologist was able to remove the stent after careful retraction.Per additional information from the ibc via email 2/18/2020, the stent was removed from the patient using a cystoscopy and forceps.No additional intervention or treatment was required according to the urologist.The urologist was able to safely remove the stent, with no major injuries.However some stone fragments caught behind the knot might have caused minor irritation of the mucosa.No supplementary medication or additional treatment was required.

• Brand Name: BARD FLUORO-4 SILICONE URETERAL COIL STENT
• Type of Device: FLUORO-4¿ COIL SILICONE URETERAL STENT 6CH MULTILENGHT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9801107
• MDR Text Key: 182456038
• Report Number: 1018233-2020-01631
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011754
• UDI-Public: (01)10801741011754
• Combination Product (y/n): N
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 277406
• Device Catalogue Number: 277406
• Device Lot Number: NGCV2405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 04/13/2020; 04/28/2020
• Supplement Dates FDA Received: 04/17/2020; 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention