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

Model Number	998506
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
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 the pressure suddenly dropped from the catheter due to the balloon burst.Per additional information received via email from the ibc on (b)(6) 2020, it was unknown whether the balloon burst occurred.
Event or Problem Description
It was reported that the pressure suddenly dropped from the catheter due to the balloon burst.Per additional information received via email from the ibc on 21aug2020, it was unknown whether the balloon burst occurred and per notification received via investigator on 01jan2021, based on the supplier evaluation it was found that the reported event aligns more to a inflation issue due to a dried contrast medium.
Additional Manufacturer Narrative
The reported event was confirmed.A balloon dilation and eagle inflation device was returned with its original packaging.The catheter sample was inspected visually under 7-20x magnification.There appears to be dried contrast media in the balloon extension portion through the y-connector hub.Upon dissolving the dried contrast media, the balloon inflated.Pressure was brought to 20atm with no sign of leak or loss of pressure.20atm was held for 5 minute.Pressure was brought to 30atm and held for 5 minutes, while no leaks or pressure loss was noted.Based on the evaluation, it appears that the customer was referring to an inflation issues caused by the contrast medium.A potential root cause of this issue could be due to possible user misuse causing the contrast medium to dry during the procedure.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." this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient".

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: URETEROSCOPIC BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10512312
• Report Number: 1018233-2020-05787
• Device Sequence Number: 16286543
• Product Code: EZN
• UDI-Device Identifier: 10801741052689
• UDI-Public: (01)10801741052689
• 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: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 04/25/2022
• Device Model Number: 998506
• Device Catalogue Number: 998506
• Device Lot Number: BMDXFM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1