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

Model Number	998606
Medical Device Problem Codes	Material Fragmentation (1261); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
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 head of the pump was found to be ruptured when the package was opened.
Event or Problem Description
It was reported that the head of the pump was found to be ruptured upon opening the package.
Additional Manufacturer Narrative
The reported event was confirmed as a use related.Photo samples were received from the customer.No cracks or ruptures were noted on the photo samples.The eagle inflation device and x-force dilation catheter were returned in the original packaging and photos of the returned sample was sent to the supplier.Based on the evaluation of the photo samples the needle gauge was not in the zero box.Debris was noted around the device however, no cracks were noted.The physical sample was received and an additional evaluation was performed.The gauge needle was not in the zero box on the physical sample no other anomalies were noted.The root cause for this failure mode would be over pressurization by the user.The device history review was not required due to the reported issue was confirmed as use related.The instructions for use were found adequate and state the following: "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 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.

• 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: 11802449
• Report Number: 1018233-2021-02701
• Device Sequence Number: 14624851
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 12/30/2021
• 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