MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS

Catalog Number	139005
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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.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.
Event or Problem Description
It was reported that during use, doctor wanted to pass a wire through the ureteral catheter but found it difficult to pass, noticed there was a kink or narrowing at proximal end of catheter.
Event or Problem Description
It was reported that during use, doctor wanted to pass a wire through the ureteral catheter but found it difficult to pass, noticed there was a kink or narrowing at proximal end of catheter.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received 8 unopened polyurethane ureteral catheters and 1 polyurethane ureteral catheter in opened packaging.Kink was present in returned sample therefore the reported event is confirmed.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be material selection.However, there was insufficient information to confirm this potential root cause.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: "indications for use: the bard polyurethane ureteral catheters are intended for use in the drainage of urine from the ureter.The polyurethane ureteral catheter is inserted through the urethra, into the bladder and up through the ureter.These catheters also allow the delivery of contrast media.Directions for use: ureteral catheters are designed in a variety of distal tip configurations.The anatomical characteristics of the ureteral orifice and physician preference should determine the choice of design in a specific clinical situation.Closed tip placement (placed without a guidewire) after placement of the cystoscope into the bladder, the ureteral orifice is located and examined and a choice of ureteral catheter is made.The catheter adapter is secured to the ureteral catheter, and the catheter is flushed to evacuate all air bubbles.Under direct vision, the catheter tip is positioned within the ureteral orifice.Contrast media is then injected through the ureteral catheter into the ureter.Under fluoroscopy, the ureter is visualized and required intervention determined.Open tip placement (placed with a guidewire) after placement of the cystoscope into the bladder, the ureteral orifice is located and examined and a choice of ureteral catheter is made.Under direct vision, the guidewire is positioned within the ureteral orifice.The ureteral catheter is inserted over the guidewire and advanced into the ureter.The guidewire is removed and the catheter adapter is secured to the catheter.Gentle aspiration to evacuate air from the catheter can be performed at this time.Contrast media is then injected through the ureteral catheter into the ureter.Under fluoroscopy, the ureter is visualized and required intervention determined.Warning: this unit should not be used as a ureteral splint.Warning: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: do not withdraw ureteral catheter while it is deflected in endoscope.Avoid sharp bending.Caution: do not over-tighten the catheter adapter.Over-tightening the catheter adapter may occlude the lumen of the catheter.Caution: when using the tigertail catheter without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force is made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible portion of the catheter become detached, retrieve with an endourology grasping device." 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® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS
• Common Device Name: URETERAL CATHETER
• 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: 19497487
• Report Number: 1018233-2024-03380
• Device Sequence Number: 18124106
• Product Code: KOD
• UDI-Device Identifier: 10801741127097
• UDI-Public: (01)10801741127097(11)231123(17)270531(10)REHX0797
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Catalogue Number: 139005
• Device Lot Number: REHX0797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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: Other
• Patient Sex: Unknown