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

Model Number	786600
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); Discomfort (2330)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the stent was longer than usual.As a result it did not curl nicely into the patient's renal pelvis, allegedly causing a lot of discomfort and pain.It was also reported that the stent knotted due to the increased length.The physician reported that the event happened with the last 3 patients.
Event or Problem Description
It was reported that the stent was longer than usual.As a result it did not curl nicely into the patient's renal pelvis, allegedly causing a lot of discomfort and pain.It was also reported that the stent knotted due to the increased length.The physician reported that the event happened with the last 3 patients.
Additional Manufacturer Narrative
The reported event is unconfirmed.The evaluation report of the returned sample, performed by futurematrix interventional, states that the stent appeared to have no physical deformities other than the missing suture.The knot was not present on the stent.Upon removing the stent from the bag, the sample was evaluated under a 7x magnification with no additional physical deformities noted.The stent was measured for overall length.The stent measured 8.69" and it should measure 8.66" +/- 0.39" (range: 8.27" - 9.05") which is within specification.The stent length was also verified at qc and the samples passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1.Determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.2.Insert the cystoscope then pass the guidewire* through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire." corrections: concomitant medical products, device evaluated by mfr.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8429671
• Report Number: 1018233-2019-01391
• Device Sequence Number: 13861497
• Product Code: FAD
• UDI-Device Identifier: 10801741015073
• UDI-Public: (01)10801741015073
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: 786600
• Device Catalogue Number: 786600
• Device Lot Number: NGBW4042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1