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

Catalog Number	998004
Medical Device Problem Codes	Material Fragmentation (1261); Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
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.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.
Event or Problem Description
It was reported that when unpacking the balloon dilation catheter during operation, the pump was found ruptured and damaged.This caused no adverse effect on the patient.
Event or Problem Description
It was reported that when unpacking the balloon dilation catheter during operation, the pump was found ruptured and damaged.This caused no adverse effect on the patient.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted one inflation device was returned to atrion inside a the inflator tray.Upon receipt of the complaint device a visual inspection was conducted.During the visual inspection, it was noted that the gauge was broken from the inflation device housings at the glue plug area.The needle on the gauge was also noted to be within the zero position.However, functional testing could not be performed on the inflation device due to the gauge being detached from the inflation device body.Also received one photo sample that showcases top view of eagle inflation pump with gauge disconnected from device.Based on physical sample received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be inappropriate package design.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "precaution: ¿ before use, inspect the device to verify that no damage has occurred during shipping and handling." 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17497923
• Report Number: 1018233-2023-05984
• Device Sequence Number: 2332065
• Product Code: EZN
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795
• 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): 12/14/2023

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: 07/14/2024
• Device Catalogue Number: 998004
• Device Lot Number: BMFQFM22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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