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

Catalog Number 788622

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

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 facility alleged the coil of the device was sharper than other coils of the same device.Another stent was used for the patient.The stent was intended to be used on the patient, but the facility used another stent.

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 facility alleged the coil of the device was sharper than other coils of the same device.Another stent was used for the patient.The stent was intended to be used on the patient, but the facility used another stent.

Manufacturer Narrative

Received only guide wire in opened package.The reported event was confirmed with an unknown cause.The sample was visually evaluated and found that the coil of the device was sharper than other usual coils of the same device.The user noticed the abnormality just after removing the monofilament.How and when problem occurred could not be determined.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: "method for use when using the multi-length type stent, it should be avoided in the following cases.If you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placement or removal.If any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter." (b)(4).

Event Description

It was reported that the facility alleged the coil of the device was sharper than other coils of the same device.Another stent was used for the patient.The stent was intended to be used on the patient, but the facility used another stent.

Manufacturer Narrative

Received only guide wire in opened package.The reported event was confirmed with an unknown cause.The sample was visually evaluated and found that the coil of the device was sharper than other usual coils of the same device.How and when problem occurred could not be determined.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: "method for use (1) when using the multi-length type stent, it should be avoided in the following cases.1) if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placement or removal.2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter." (b)(4).

Event Description

It was reported that the facility alleged the coil of the device was sharper than other coils of the same device.Another stent was used for the patient.The stent was intended to be used on the patient, but the facility used another stent.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Type of Device: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• MDR Report Key: 6545663
• MDR Text Key: 74596242
• Report Number: 1018233-2017-02275
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

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 Expiration Date: 01/01/2019
• Device Catalogue Number: 788622
• Device Lot Number: MYANT861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 07/25/2017; 02/07/2018
• Supplement Dates FDA Received: 05/18/2017; 08/21/2017; 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1