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

Catalog Number	139004
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tigertail 4fr was used for surgery on the renal pelvis of an infant (1 and a half years old).During the operation, the tip of the tiger tail (black part) was removed and remained inside the infant's body.The operation was completed with the tip remaining in the body due to the severely invasive nature of the procedure.It will be removed at a later date.It was unknown what medical intervention was provided.Per additional information received via email on 18may2024, it was reported that the invasiveness did not become more severe after using tiger tail, but the original surgery itself was highly invasive.
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 was confirmed ¿ supplier related.The product had caused the reported failure.Sample has been evaluated and observed the pigtail of tiger tail (black part) was breakage.The potential root cause for this failure mode could be supplier defect or user related.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: "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.2.Precaution of use 1) inserting the ureteral catheter, especially without the stabilizing support of a guidewire, be aware that ta 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 dissected 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." correction: d 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 tigertail 4fr was used for surgery on the renal pelvis of an infant (1 and a half years old).During the operation, the tip of the tiger tail (black part) was removed and remained inside the infant's body.The operation was completed with the tip remaining in the body due to the severely invasive nature of the procedure.It will be removed at a later date.It was unknown what medical intervention was provided.Per additional information received via email on 18may2024, it was reported that the invasiveness did not become more severe after using tiger tail, but the original surgery itself was highly invasive.

• 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: 19407932
• Report Number: 1018233-2024-03005
• Device Sequence Number: 15528626
• Product Code: KOD
• UDI-Device Identifier: 10801741127080
• UDI-Public: (01)10801741127080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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 Catalogue Number: 139004
• Device Lot Number: MYGT1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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: Required Intervention
• Patient Age: 18 MO
• Patient Sex: Unknown