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

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	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use, doctor could not pass a wire through the ureteral catheter due to the catheter kinked or has a narrowing at proximal end.They opened a new catheter.
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 before use, doctor could not pass a wire through the ureteral catheter due to the catheter kinked or has a narrowing at proximal end.They opened a new catheter.
Additional Manufacturer Narrative
The reported event is inconclusive due to the condition of the sample received.Visual: received 3 photo samples.First photo sample shows top view of document titled "movement of goods".Second photo sample shows tigertail catheter enclosed within clear packaging.Third photo sample shows top view of product packaging of 8 tigertail catheters.Based on photo sample received the samples cannot be tested for the reported event therefore the reported event is inconclusive.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 inappropriate package design.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: "bard tigertail flexible tip ureteral catheter: do not reuse: contraindications - method for use: 1.Do not reuse.2.Do not resterilize.Shape, configuration and principles the bard tigertail flexible tip ureteral catheter consists of the following items.Ureteral catheter: opened tip type, 1 tip eye material: polyurethane adapter: note: the back-end of these catheters is classified as for the right side (red marking) and for the left side (blue marking).Adapter: purpose and effects: these ureteral catheters of radiopaque are intended for use in urine drainage, collection of urine samples and pyelography with insert through the urethra into the ureter or renal pelvis.Direction for use: 1.Method of use: dispense after single use and do not reuse since the device is a disposable product intended only for single use.(1) placement without a guidewire 1) the ureteral catheter is inserted into the ureter under endoscopy.2) the catheter adapter is secured to the terminal end of the ureteral catheter, and the urine drainage or retrograde pyelography is performed.3) withdraw the ureteral catheter from the endoscope and the procedures are completed.(2) placement with a guidewire 1) the guidewire is inserted into the ureter under endoscopy.2) the ureteral catheter is inserted over the guidewire and advanced into the ureter.3) after withdrawing the guidewire, the catheter adapter is secured to the terminal end of the ureteral catheter, and the urine drainage or retrograde pyelography is performed.4) withdraw the ureteral catheter from the endoscope and the procedures are completed.2.Precaution for use: (1) inserting the ureteral catheter, especially 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 tip portion of the catheter become detached, consider retrieval with an endourology grasping device (2) do not withdraw ureteral catheter while it is deflected in endoscopy.It is possible that the catheter may dissect or fracture.(3) avoid sharp bending.(4) do not over-tighten the catheter adapter.Over-tightening the catheter adapter may occlude the lumen of the catheter.Precautions: 1.Malfunction and adverse events: (1) malfunction: kink, damage or breakage, occlusion of inner lumen, insertion difficulty, removal difficulty.(2) adverse events: urinary tract infarction, bleeding, hematuria, allergic reactions to the device -hypotension/hypertension, pain, ureteral injury, renal pelvic injury - remaining of breakage piece, storage method and expiration date.1.Storage: store in a dry, cool place, keeping away from heat, moisture and direct sunshine.2.Expiration date: indicated on the direct package and outer carton." 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 STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 19547217
• Report Number: 1018233-2024-03511
• Device Sequence Number: 4734989
• 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): 08/29/2024

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: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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