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

Model Number 788626

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problems Patient Problem/Medical Problem (2688); Insufficient Information (4580)

Event Date 08/29/2020

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 optima weren't able to remove after implant into patient for 3 month.Patient was required to go back to operation room under general anesthesia to remove optima instead of local anesthesia.Per additional information received via mail from ibc on 17 sep 2020, optima was removed using endoscope.

Manufacturer Narrative

The reported event was confirmed.A ureteral stent was returned opened without its original packaging.The sample was found to be deformed with hard pebble-like of material found.The hardened parts of the stent was found to be embedded with the pebble like material.The photo samples returned from the customer shows the stent immediately after it was removed from the patient.The photo samples shows damage and calcification on the stent in multiple locations.The cause of the removal issue appears to be the device calcification.As the device was used and removed via a surgery a new complaint will not be opened for the damaged stent.A potential root cause of the calcification issue could be due to " material selection¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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".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 optima weren't able to remove after implant into patient for 3 month.Patient was required to go back to operation room under general anesthesia to remove optima instead of local anesthesia.Per additional information received via mail from ibc on (b)(6) 2020, optima was removed using endoscope.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10560395
• MDR Text Key: 207733332
• Report Number: 1018233-2020-06088
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015762
• UDI-Public: (01)00801741015762
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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 Model Number: 788626
• Device Catalogue Number: 788626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/30/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention