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

Model Number	998706
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
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.The device was not returned.
Event or Problem Description
It was reported that the pressure pump was broken and functioned improperly, so water leakage occurred in the ureteral balloon catheter during inflation.It was also stated then a new balloon kit was used.
Event or Problem Description
It was reported that the pressure pump was broken and functioned improperly, so water leakage occurred in the ureteral balloon catheter during inflation.It was also stated then a new balloon kit was used.Per follow via ibc on 14apr2022, it was stated that the pressure pump broke and it caused a leak.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.No physical sample was returned, however, a photo sample was provided.There appears to be a crystalized substance along the outer junction of the clamp assembly.The presence of such a substance suggests the device was utilized during a procedure, as reported by the customer.An accumulation of the crystalized substance in this location may also result from over-pressurization of the device causing the o-ring to become permanently dislocated by forcing it out of its assembled position and allowing the device to leak.The complaint device in the photo sent strongly resembles a device that has been over-pressurized but that observation could not be confirmed without a physical examination of the device.A potential root cause for this event could be over pressurization by the user.The device was used for treatment purposes.It was unknown if the device had met all relevant specifications or caused the reported event.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: "before use, inspect the device to verify that no damage has occurred during shipping and handling." eagle inflation device drawing 96329 was reviewed and found to be adequate as it shows the inflation gauge which states "do not exceed 30 atm" 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® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14135071
• Report Number: 1018233-2022-02599
• Device Sequence Number: 12335161
• 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): 08/09/2022

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: 02/01/2024
• Device Model Number: 998706
• Device Catalogue Number: 998706
• Device Lot Number: BMFXFM06
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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