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

Catalog Number 787426

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

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.

Event Description

It was reported that the customers stated that the guidewire of their recent bracket was significantly thicker than the stent.The guide wire used with the 426 stent was thicker than the 0.035 guidewires resulting in over tightening and difficulty in operation during use.The health care professional had a poor customer use issue.

Event Description

It was reported that the customers stated that the guidewire of their recent bracket was significantly thicker than the stent.The guide wire used with the 426 stent was thicker than the 0.035 guidewires resulting in over tightening and difficulty in operation during use.The health care professional had a poor customer use issue.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be incorrect line clearance.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 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 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.Urethral catheters, and polymers intended for urological use,¿ bju international (2000), 86, 414-421.Contraindications: no known contraindications for use." 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.

• 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: 18132316
• MDR Text Key: 328631678
• Report Number: 1018233-2023-08108
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015363
• UDI-Public: (01)10801741015363
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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 Number: 787426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/29/2024
• 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): Other