MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® BALLOON DILATION CATHETER; X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER

Model Number	998606
Medical Device Problem Codes	Fracture (1260); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 the pump head of the balloon dilation catheter was found to be cracked when the package was opened.
Additional Manufacturer Narrative
The reported event was confirmed as use related.The dilation catheter and eagle inflation device were returned in the original packaging.The needle gauge was not in the zero position when the device was received.The right clamp on the device was observed to be cracked and broken.No other anomalies were noted.The root cause for this failure mode was due to over pressurization by the user.Per investigation the device history record review was not required.The instructions for use were found adequate and state the following: "the lumen labeled with the rated burst pressure (xx atm) is for balloon inflation do not exceed the recommended rated burst pressure (rbp) 30 atm for this device.Balloon rupture may occur if the rbp rating is exceeded." 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 pump head of the balloon dilation catheter was found to be cracked upon opening the package.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: X-FORCE U30 URETEROSCOPIC 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: 11921499
• Report Number: 1018233-2021-03177
• Device Sequence Number: 3215709
• 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): 12/13/2021

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: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMDXFM06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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