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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE Back to Search Results
Catalog Number 786600
Device Problems Knotted (1340); Difficult to Remove (1528)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that a knot was confirmed upon removal of the device at the periodic replacement.It was later reported that there was difficulty removing the device and the patient alleged pain during removal.There was additional blood upon removal, however there was no additional intervention reported.The original stent removal was routine, and the additional replacement surgery was for standard replacement.
 
Event Description
It was reported that a knot was confirmed upon removal of the device at the periodic replacement.It was later reported that there was difficulty removing the device and the patient alleged pain during removal.There was additional blood upon removal, however there was no additional intervention reported.The original stent removal was routine, and the additional replacement surgery was for standard replacement.
 
Manufacturer Narrative
Received knotted stent for evaluation.The reported event was confirmed as cause unknown.It was unable to be determined how and when the event occurred.The sample was sent to the supplier for further investigation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "[warnings] 1.Method for use (1)when using the multi-length type stent, it should be avoided in the following cases.1)if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil part shave risks of knot formation at the tip of renal pelvis side during placement or removal.1) 2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.(2) ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care.[contraindications] 1.Method for use (1)do not reuse.(2)do not resterilize 2.Applicable patients do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre-born baby from x-ray.]".
 
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Brand Name
BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE
Type of Device
URETERAL STENT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7374664
MDR Text Key103691439
Report Number1018233-2018-00974
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number786600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Initial Date Manufacturer Received 03/09/2018
Initial Date FDA Received03/27/2018
Supplement Dates Manufacturer Received05/15/2018
Supplement Dates FDA Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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