MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Catalog Number 787420

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Peritonitis (2252)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the critical care nurses reported in a pmcf that the patient experienced an adverse event directly atributable to the device 787422 - inlay optima® ureteral stent with hydroglide¿ guidewire, 4.7 fr.X 22cm and the patient experienced "peritonitis".The event did result in the patient injury requiring medical or surgical intervention (dj anlage).

Event Description

It was reported that the critical care nurses reported in a pmcf that the patient experienced an adverse event directly atributable to the device 787422 - inlay optima® ureteral stent with hydroglide¿ guidewire, 4.7 fr.X 22cm and the patient experienced "peritonitis".The event did result in the patient injury requiring medical or surgical intervention (dj anlage).

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the critical care nurses reported in a pmcf that the patient experienced an adverse event directly atributable to the device 787420 - inlay optima® ureteral stent with hydroglide¿ guidewire, 4.7 fr.X 22cm and the patient experienced "peritonitis".The event did result in the patient injury requiring medical or surgical intervention (dj anlage).

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be material selection.However, there was insufficient information to confirm this potential root cause.The potential failure mode is patient device incompatibility.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications for use: the inlay optima® ureteral stent and multi-length ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter.These conditions include stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.It is recommended that the indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Description: the inlay optima® ureteral stent and multi-length ureteral stent is a coated, double pigtail ureteral stent with a monofilament suture loop attached to aid in stent removal.The stent is available in two forms: a single size or a customizable multi-length size.The following items are included with each stent: 1 ureteral stent with suture 1 push catheter with radiopaque band 1 pigtail straightener 1 guidewire* (optional) *note: a 4.7 fr stent is compatible with a.035¿ guidewire and 6, 7, and 8 fr stents are compatible with a.038¿ guidewire.In vitro testing conducted on the inlay optima® ureteral stent and multi-length ureteral stent indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control.Correlation of in vitro data to clinical outcome has not been established.Choong, sks, wood, s, whitfield, hn.¿a model to quantify encrustation on ureteric stents, urethral catheters, and polymers intended for urological use,¿ bju international (2000), 86, 414-421.Contraindications: no known contraindications for use.Precautions: ¿ suture may be cut off prior to stent placement.Remove suture if indwelling time is expected to be longer than 14 days.¿ avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.¿ ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.* ¿ with any ureteral stent, migration is a possible complication, which could require medical intervention for removal.Selection of too short a stent may result in migration.¿ care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation.¿ the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." corrections: b, e, f, h h11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18977850
• MDR Text Key: 338587378
• Report Number: 1018233-2024-01572
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015332
• UDI-Public: (01)10801741015332
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 787420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/02/2024; 05/08/2024
• Supplement Dates FDA Received: 04/10/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other