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

Catalog Number 996101

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

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 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.

Event Description

It was reported that once the package was opened, the doctor found that the balloon pump was damaged on the balloon dilation catheter.The device was not used in the patient.It was stated that they replaced with a new balloon.Per additional information via email from ibc on 26sep2023, the balloon pump indicating balloon of the dilation cathter and the damage indicating ballon burst.

Event Description

It was reported that once the package was opened, the doctor found that the balloon pump was damaged on the balloon dilation catheter.The device was not used in the patient.It was stated that they replaced with a new balloon.Per additional information via email from ibc on 26sep2023, the balloon pump indicating balloon of the dilation cathter and the damage indicating ballon burst.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted the sample was received in a closed ziploc bag identified with a label with the customer complaint and additionally a biohazard label and sterilized by eo label.Inside of the bag there was the tyvek pouch with unit label identifying and lot number bmgxfm31, beside the tyvek pouch there was another ziploc bag with the balloon catheter and the stopcock attached.The balloon hub of the catheter reads " 10mm x 15 cm" and "30 atm" and the wire hub reads "0.038(0.97mm) wire." visual inspection was performed to the catheter, no damages were observed in the balloon, however it was identified that the balloon hub connector it was fully cracked.The stopcock was inspected and there are no signs of damages on it.The balloon hub was inspected under magnification and there are no visible marks of over torque in the hub connector, however, it was noticed that most of the cracks are exactly in the opposite director as the connector was crushed in those spots.Manufacturing process was reviewed and it was confirmed that there is no tolling that can crush the hub connector in the way it is seen in the sample received.Although an exact root cause could not be determined a potential root cause could be inappropriate package design.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: "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® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: 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: 17894825
• MDR Text Key: 325391530
• Report Number: 1018233-2023-07261
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 996101
• Device Lot Number: BMGXFM31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other