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

Model Number	998004
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
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.
Event or Problem Description
It was reported that after the insertion into the urethra, dilatation was attempted, but could not be achieved under fluoroscopic guidance and the catheter was removed from the body.Afterwards, it was found that there was water leakage from the balloon when checked under direct vision.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Photo samples were submitted by the customer, however, no visible defects were noted from the photos.The physical sample was returned with the inflation device in an open packaging.A potential root cause for this event could be, "poor balloon design (inadequate wall thickness/strength), inadequate material selection, contact with stone".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: "extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi." "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." "inspection prior to use 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." "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 bard 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 bard.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that after the insertion into the urethra, dilatation was attempted, but could not be achieved under fluoroscopic guidance and the catheter was removed from the body.Afterwards, it was found that there was water leakage from the balloon when checked under direct vision.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12546636
• Report Number: 1018233-2021-06067
• Device Sequence Number: 4068455
• Product Code: EZN
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• 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): 03/03/2022

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: 07/01/2022
• Device Model Number: 998004
• Device Catalogue Number: 998004
• Device Lot Number: BMDZFM33
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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: Male