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

Model Number 997604

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.

Event Description

It was reported that after breaking the package, the putter was found to be damaged.It was later reported per additional information received from the ibc,that the package was not broken.The putter was damaged when the package was opened.The type of damage is currently unknown.

Event Description

It was reported that after breaking the package, the putter was found to be damaged.It was later reported per additional information received from the ibc,that the package was not broken.The putter was damaged when the package was opened.The type of damage is currently unknown.

Manufacturer Narrative

The reported event was unconfirmed.The complaint states that "the putter was found to be damaged" and "the putter is a push rod that is a passage for passing the guidewire and water in the balloon." per the evaluation report of the returned sample, submitted by futurematrix interventional, noted that biomerics (futurematrix interventional) does not manufacture nor package push rods or catheter extensions for use with the x-force catheter.The instruction for use states "the x-force® balloon dilation catheter comes packaged with a refolding tool and is available with or without an inflation device." it does not indicate a putter or push rod or any use thereof.Therefore, the failure cannot be replicated.It also cannot be determined if the device was used properly.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: ¿warnings ¿ do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.¿ 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.Precautions caution: federal law (u.S.A.) restricts this device to sale by or on the order of a physician.Only a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract should use this device.After use, the x-force® balloon dilation catheter and/or accessories may be considered a potential biohazard.Handle and dispose of in accordance with medical practice and applicable laws and regulations.Inspection prior to use the x-force® balloon dilation catheter is a sterile, single patient use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Type of Device: BARD® X-FORCE® BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8515794
• MDR Text Key: 142058587
• Report Number: 1018233-2019-01954
• Device Sequence Number: 1
• Product Code: EZN
• UDI-Device Identifier: 00801741052095
• UDI-Public: (01)00801741052095
• Combination Product (y/n): N
• PMA/PMN Number: K050875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 997604
• Device Catalogue Number: 997604
• Device Lot Number: BMATFM34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1