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

Catalog Number 786624

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the glide wire was broken off.There were broken pieces in the ureteral catheter.

Event Description

It was reported that the glide wire was broken off.There were broken pieces in the ureteral catheter.

Manufacturer Narrative

The reported event was confirmed.The visual evaluation found that the guidewire was broken into several pieces.The sample was sent to the supplier for further investigation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "insertion of the guidewire remove the guidewire from the packaging, together with the guidewire holder.Prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.Remove the guidewire from the guidewire holder.Before using the guidewire, confirm the surface slides well when removing it from the holder.If you feel any resistance, do not force it, and inject the normal saline solution into the holder again, then try pulling it out once more.Insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.Advance the guidewire into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy.".

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Type of Device: INLAY OPTIMA STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7480174
• MDR Text Key: 107333017
• Report Number: 1018233-2018-01421
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 786624
• Device Lot Number: MYBYT939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1