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

Catalog Number 786426

Device Problem Partial Blockage (1065)

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

Event Date 09/12/2023

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 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 when in use during operation, the stent was found occluded so that the urine could not be drained.As per the follow up information received via ibc on 20sep2023, the ureteral stent was used for laparoscopic right ureteral bladder replantation and was replaced with a new stent when the stent was found to be blocked during intraoperative use and urine could not be drained.

Manufacturer Narrative

The reported event is unconfirmed as the product meets specifications.Visual evaluation noted visual requirements state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.No defects were evaluated while performing the visual inspection.The suture and pigtail straightener were not provided for evaluation.Dimensional evaluation noted dimensional requirements state the od is to be 0.061" ± 0.002" and the guidewire to be 0.035" ± 0.001".The sample passed od measuring at 0.0627" using a laser micrometer.When inserting the guidewire there was no hesitation.No root cause could be found because the reported event was unconfirmed.A dhr reviews are not required for this complaint.The labelling review is not required as the reported event is unconfirmed.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 actual/suspected device was inspected.

Event Description

It was reported that when in use during operation, the stent was found occluded so that the urine could not be drained.As per the follow up information received via ibc on 20sep2023, the ureteral stent was used for laparoscopic right ureteral bladder replantation and was replaced with a new stent when the stent was found to be blocked during intraoperative use and urine could not be drained.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ 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: 17903904
• MDR Text Key: 325268286
• Report Number: 1018233-2023-07281
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015042
• UDI-Public: (01)10801741015042
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 786426
• Device Lot Number: NGGW1576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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