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

Catalog Number	788814
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a transplanted kidney needed percutaneous stenting of the ureter.During placement, a catheter was used to push the stent into place in the ureter over a stiff guidewire.Despite the stiffness of the guidewire, which cannot be stiffer due to vulnerable tissue in the kidney, the radiopaque tip of the catheter broke and must have been left inside the renal pelvis for future surgical removal.Per follow-up information received from ibc on (b)(6) 2023, stated that the broken off tip of the push catheter was extracted from the kidney surgically via percutaneous nephrolithotomy.The extracted broken off tip was not sterilized, but it was in a small container.There was no cytotoxic material, but it might have traces of blood.The patient impact was that the patient had to undergo a percutaneous nephrolithotomy (pnl) procedure in general anesthesia, where they extracted the broken off tip via a percutaneous access into the kidney pelvis.No complications happened during this procedure, but there was inherent risk associated with it.There were two other occurrences of tips breaking off and they could be extracted with cystoscopic access through the ureter, also in general anesthesia.Per follow-up information received from ibc on (b)(6) 2023, stated that the tip snapped off the pusher catheter and stayed inside the patient until surgically removed.The rest of the pusher catheter could be retracted as usual.Per follow-up information received from ibc on (b)(6) 2023, stated that they have the broken off tip of the push catheter, used and extracted from the kidney surgically (via percutaneous nephrolithotomy).It was not sterilized, but it is in a small container.No cytotoxic material, but might have traces of blood.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted sample was visually inspected in the laboratory, and it was noticed that there are 4 indentations; two are in the mid-section and other two are in the proximal end of the black tip.There are no traces of the orange welded tube.Dimensional evaluation noted the id and od of the tip were measured resulting in an id of 0.043" and an od of 0.010760".Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.Care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." h11: section a through f - the information provided by bd represents all 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.H3 other text: the actual/suspected device was inspected.
Event or Problem Description
It was reported that a patient with a transplanted kidney needed percutaneous stenting of the ureter.During placement, a catheter was used to push the stent into place in the ureter over a stiff guidewire.Despite the stiffness of the guidewire, which cannot be stiffer due to vulnerable tissue in the kidney, the radiopaque tip of the catheter broke and must have been left inside the renal pelvis for future surgical removal.Per follow-up information received from ibc on 18aug2023, stated that the broken off tip of the push catheter was extracted from the kidney surgically via percutaneous nephrolithotomy.The extracted broken off tip was not sterilized, but it was in a small container.There was no cytotoxic material, but it might have traces of blood.The patient impact was that the patient had to undergo a percutaneous nephrolithotomy (pnl) procedure in general anesthesia, where they extracted the broken off tip via a percutaneous access into the kidney pelvis.No complications happened during this procedure, but there was inherent risk associated with it.There were two other occurrences of tips breaking off and they could be extracted with cystoscopic access through the ureter, also in general anesthesia.Per follow-up information received from ibc on 25aug2023, stated that the tip snapped off the pusher catheter and stayed inside the patient until surgically removed.The rest of the pusher catheter could be retracted as usual.Per follow-up information received from ibc on 04sep2023, stated that they have the broken off tip of the push catheter, used and extracted from the kidney surgically (via percutaneous nephrolithotomy).It was not sterilized, but it is in a small container.No cytotoxic material, but might have traces of blood.Per mail received from customer on 06sep2023, stated that there were three occurrences in total at the institution.Each happened to a different patient on different dates like (b)(6) 2022, (b)(6) 2023 and (b)(6) 2023.
Event or Problem Description
It was reported that a patient with a transplanted kidney needed percutaneous stenting of the ureter.During placement, a catheter was used to push the stent into place in the ureter over a stiff guidewire.Despite the stiffness of the guidewire, which cannot be stiffer due to vulnerable tissue in the kidney, the radiopaque tip of the catheter broke and must have been left inside the renal pelvis for future surgical removal.Per follow-up information received from ibc on 18aug2023, stated that the broken off tip of the push catheter was extracted from the kidney surgically via percutaneous nephrolithotomy.The extracted broken off tip was not sterilized, but it was in a small container.There was no cytotoxic material, but it might have traces of blood.The patient impact was that the patient had to undergo a percutaneous nephrolithotomy (pnl) procedure in general anesthesia, where they extracted the broken off tip via a percutaneous access into the kidney pelvis.No complications happened during this procedure, but there was inherent risk associated with it.There were two other occurrences of tips breaking off and they could be extracted with cystoscopic access through the ureter, also in general anesthesia.Per follow-up information received from ibc on 25aug2023, stated that the tip snapped off the pusher catheter and stayed inside the patient until surgically removed.The rest of the pusher catheter could be retracted as usual.Per follow-up information received from ibc on 04sep2023, stated that they have the broken off tip of the push catheter, used and extracted from the kidney surgically (via percutaneous nephrolithotomy).It was not sterilized, but it is in a small container.No cytotoxic material, but might have traces of blood.Per mail received from customer on 06sep2023, stated that there were three occurrences in total at the institution.Each happened to a different patient on different dates like (b)(6) 2022, (b)(6) 2023 and (b)(6) 2023.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted sample was visually inspected in the laboratory, and it was noticed that there are 4 indentations; two are in the mid-section and other two are in the proximal end of the black tip.There are no traces of the orange welded tube.Dimensional evaluation noted the id and od of the tip were measured resulting in an id of 0.043" and an od of 0.010760".Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." directions for use: 4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.7.Carefully remove the push catheter.Correction: d.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17690280
• Report Number: 1018233-2023-06599
• Device Sequence Number: 20341682
• Product Code: FAD
• UDI-Device Identifier: 00801741015885
• UDI-Public: (01)00801741015885(11)210914(17)240314(10)NGFW1819
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2024
• Device Catalogue Number: 788814
• Device Lot Number: NGFW1819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 11/05/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/09/2023; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown