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

Model Number	139005
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the tigertail ureteral catheter was curling, and was not allowing the guidewire to pass through it (batch # regx3459).Per additional information received via email on 17mar2023, stated that the an additional batch# also had the same issue (batch # regw2678).Per additional information received via email on 23mar2023, stated that they were not sure whether some of the device came into contact with a patient.Certainly many were opened and then determined to be defective when guide wire was not able to pass the crimp.There was no patient harm noted.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample.The physical sample was not returned, however, a photo of the catheter packaging was provided showing the product identifiers.The reported event could not be evaluated with the provided photo.Though a specific cause cannot be determined, a potential root cause for this event could be tubing strength insufficient.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states 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.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." 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 the tigertail ureteral catheter was curling, and was not allowing the guidewire to pass through it (batch # regx3459).As per additional information received via email on 17mar 2023, stated that the an additional batch# also had the same issue (batch # regw2678).As per additional information received via email on 23mar2023, stated that they were not sure whether some of the device came into contact with a patient.Certainly many were opened and then determined to be defective when guide wire was not able to pass the crimp.There was no patient harm noted.As per additional information received via email on 26jul2023, stated that the device was used in patients.The evaluation and final conclusion was not based on evidence and problem encountered.The ureteral catheter as it came out the package was not adequate or useable.The catheter end under the clear part or under the white part of the adaptor was already crumpled.The adaptor actually was loosened, not tightened (batch # regx3459 and batch # regw2678).Therefore it was not allowing anything to pass, including a wire, through the catheter.

• Brand Name: BARD® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS
• Common Device Name: URETERAL CATHETERS
• 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: 16662757
• Report Number: 1018233-2023-02235
• Device Sequence Number: 20484728
• Product Code: KOD
• UDI-Device Identifier: 10801741127097
• UDI-Public: (01)10801741127097
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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 Model Number: 139005
• Device Catalogue Number: 139005
• Device Lot Number: REGX3459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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