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

Model Number	998006
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
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 the patient underwent urethral stricture balloon dilatation on (b)(6) 2022.During the operation, a balloon was inserted, and the balloon was dilated after filling with water.After drawing the water out, the ureteroscopic balloon dilation catheter could not be pulled out from the urethra.After the balloon was finally pulled out, a break was found in the balloon.Urethroscopy was performed immediately and it was found that the patient¿s urethra was not dilated and there was still scar stenosis.Then, urethral stricture scar resection was performed.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned and further investigation was not conclusive.Though a specific cause cannot be determined, a potential root cause for this event could be, "poor balloon design".The device was used for treatment purposes.It is unknown if the device had met relevant specifications or resulted in 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: "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." "warning: do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi." "caution: if resistance is felt when removing either the catheter or the guidewire from the introducer sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation." 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 device was not returned.
Event or Problem Description
It was reported that the patient underwent urethral stricture balloon dilatation on (b)(6) 2022.During the operation, a balloon was inserted, and the balloon was dilated after filling with water.After drawing the water out, the ureteroscopic balloon dilation catheter could not be pulled out from the urethra.After the balloon was finally pulled out, a break was found in the balloon.Urethroscopy was performed immediately and it was found that the patient¿s urethra was not dilated and there was still scar stenosis.Then, urethral stricture scar resection was performed.

• 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: 16014814
• Report Number: 1018233-2022-09714
• Device Sequence Number: 7340631
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Expiration Date: 05/15/2023
• Device Model Number: 998006
• Device Catalogue Number: 998006
• Device Lot Number: BMFQFM13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male