MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® BALLOON DILATION CATHETER; X-FORCE URETERAL DILATION BALLOON CATHETER KIT

Model Number	998706
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection of the balloon dilation catheter prior to operation, the doctor found that the balloon leaked water when being inflated using a pump.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 inspection of the balloon dilation catheter prior to operation, the doctor found that the balloon leaked water when being inflated using a pump.Per additional information via email from ibc on 27sep2022, it was confirmed that leak was coming from the balloon.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The used x-force balloon dilation catheter was returned in the opened original packaging.An evaluation was completed by futurematrix on 05dec2022.Potential root cause for this event could be, "shaft wall too thin".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.Based on the results of the investigation no additional action is required at this time.The instructions for use were found adequate and state the following: "do not exceed the recommended rated burst pressure (rbp) for this device." "only a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract should use this device." "the x-force® balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident." "store the balloon dilation catheter in a cool, dry, dark place.Do not store near radiation or ultraviolet light sources as these may damage product materials." h11: section a through f - the information provided by bd represents all of 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.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: X-FORCE URETERAL DILATION BALLOON CATHETER KIT
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14988437
• Report Number: 1018233-2022-05353
• Device Sequence Number: 19303001
• Product Code: EZN
• UDI-Device Identifier: 10801741052740
• UDI-Public: (01)10801741052740
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• 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): 12/19/2022

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 Expiration Date: 08/29/2022
• Device Model Number: 998706
• Device Catalogue Number: 998706
• Device Lot Number: BMEPFM18
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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