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

Model Number	998504
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the placement, a contrast medium was injected to inflate the balloon, but the balloon did not inflate.When the ureteral dilation balloon catheter was removed from the body and visually examined, water leakage was observed due to the balloon rupture.
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 placement, a contrast medium was injected to inflate the balloon, but the balloon did not inflate.When the ureteral dilation balloon catheter was removed from the body and visually examined, water leakage was observed due to the balloon rupture.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Photo samples were submitted, however, no defects were noted on the provided photos.The balloon dilation catheter was returned with the opened original packaging.An evaluation of the physical sample was completed by futurematrix on 18may2022.A significant amount of dried, white crystal-like material was present inside the balloon; possibly decontamination residue and/or contrast material.No damage was noted on the outer shaft and no defects were noted within the hubs assembly.Port holes, bullets and markers were all present and non non-conformities were noted.An in-house 0.038" guidewire was used and passed freely per specifications.With the guidewire left in place, an inflation device was attached to simulate inflation.The balloon was difficult to inflate due to the amount of substance inside the balloon.The device was sat in warm water to try and break up the crystal-like material.Inflation was attempted once more and the balloon was inflated by increasing atm pressure.A small leak was noted at the proximal cone location on the balloon.Once the water was removed, and inflation device detached, the balloon portion was examined under 7-10x magnification.There is evidence of what looks like a small flap or scrape type opening on the balloon in the direction of insertion.The flap would pull back towards the proximal end and not towards the tip of the device.A potential root cause for this event could be "poor balloon design )molecular orientation, wall thickness)." 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: "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." "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." "preparation of the catheter all x-force® balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock and draw back on the inflation device to remove the air from the balloon catheter.4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen." "inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile diluted contrast medium.2.Attach the inflation device to the balloon lumen.3.Inflate the balloon" "note: do not use air or any gaseous substances as a balloon inflation medium always use sterile liquid media." "note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the rated burst pressure of the balloon is not exceeded." "caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to re-inflate the balloon.If after inspection it is noted pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible.'' correction: d,h 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.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13791585
• Report Number: 1018233-2022-01351
• Device Sequence Number: 3733473
• Product Code: EZN
• UDI-Device Identifier: 10801741052672
• UDI-Public: (01)10801741052672
• 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): 05/31/2022

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: 09/30/2022
• Device Model Number: 998504
• Device Catalogue Number: 998504
• Device Lot Number: BMEYFM13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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