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

Catalog Number	998606
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon leaked water in the balloon dilation catheter when being filled with water.
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 is confirmed cause unknown.Visual evaluation noted the sample was received in a closed ziploc bag identified with customer complaint , a biohazard label and sterilized by eto label.Inside the ziploc bag there was the catheter's tray and the unit label indicating product code 998606 and lot number bmgsfm14.Inside the tray there was the balloon catheter.The balloon hub reads 6 mm x 6cm/ 30 atm and wire hub reads 0.038 (0.97 mm) wire.The sample was evaluated in the bio testing lab, first performing a visual inspection of the device and no visible anomalies were identified.Functional evaluation noted upon completion of the visual inspection, a functional testing was performed inserting a 0.038" guidewire through the wire hub; the guidewire was able to pass freely through all the catheter inner lumen.Then the balloon catheter was filled with distilled water using an inflation device.The balloon was inflated, and there was a small leak when it was pressurized to 2 atm.The leak was located in the distal cone of the balloon.Balloon fibers were removed to determine the precise location of the leak, and it was observed that the leak was due to marginal damage in the transition between distal cone and glue joint.Although an exact root cause could not be determined a potential root cause could be pre attachment of stopcock to balloon hub with material of similar rigidity.The dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: inspection prior to use the x-force® nephrostomy 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 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the balloon leaked water in the balloon dilation catheter when being filled with water.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17692146
• Report Number: 1018233-2023-06616
• Device Sequence Number: 6057443
• Product Code: EZN
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• 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): 11/15/2023

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 Expiration Date: 10/07/2024
• Device Catalogue Number: 998606
• Device Lot Number: BMGSFM14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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