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

Catalog Number 788600

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Shock (2072); Reaction (2414)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that allergic symptoms were observed on the patient a short while after the stent was inserted.The patient recovered after the treatment.Per additional information received by the ibc representative on 16-oct-19, the patient allergies were unknown and the course of treatment was unknown.

Event Description

It was reported that allergic symptoms were observed on the patient a short while after the stent was inserted.The patient recovered after the treatment.Per additional information received by the ibc representative on 16-oct-19, the patient allergies were unknown and the course of treatment was unknown.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure mode could be allergic metal issue.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: ¿b) stent -avoiding improper handling which may affect integrity of this device including bending, kinking or tearing - exercise caution to avoid damaging the stent with sharp instrumens.This may cause this device to tear, break or fragment.Determine proper stent length for the patient by a physicians.Selection of too short a stent may result in migration.The surture attached to the stent may be cut off prior to or after placement.Remove the surture before placing the stent in children.Any sign of infection in the location of the stent placement require removal of the stent.After checking the condition of the patient, a new stent should be placed.Care should be exercised when removing the stent to eliminate tearing or fragmentation.".

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT
• Type of Device: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9252222
• MDR Text Key: 164240625
• Report Number: 1018233-2019-06908
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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: 788600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR