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

Model Number 887604

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

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 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 Description

It was reported that a piece of the catheter balloon came off in the patient during surgery.The complainant alleges that the piece was removed before surgery was completed.No patient injury was reported.

Manufacturer Narrative

Received 1 used uroforce dilation catheter with the original unit packaging.The investigation was confirmed for the material rupture, but the root cause was unknown due to the missing material.The following items were received in the pouch: one piece of ¿thread¿ , it was 38.14 inches long one balloon catheter: overall length: 76cm extension labeling: ¿balloon 6mmx4cm¿ and ¿rbp 20atm¿ the balloon was found to be ruptured but it was unable to be determined if there was a piece of the balloon material missing.The balloon edges could not be re-aligned due to the longitudinal rupture.Additionally, the piece that was allegedly retrieved from the patient was not returned with the sample.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "the uroforce balloon dilation catheter is a dual-lumen catheter with a nydex balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define working length.The lumen labeled ¿balloon¿ is for balloon inflation.The other lumen allows the catheter to track over a 0.038¿ (.97mm) diameter guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.Each balloon inflates to a stated diameter and length at a specific pressure--typically at 10 atm.The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a profile reducing sheath that is positioned over the balloon for protection before use.A stylet is inserted in the distal (guidewire) lumen beneath the balloon to prevent kinking during shipment and storage.Indications for use: uroforce balloon dilation catheters are recommended for dilation of the urinary tract.Contraindications: do not use the uroforce balloon dilation catheter to treat obstruction that is due to extrinsic factors.Warnings: do not exceed the recommended maximum balloon inflation pressure that is stated on the label.Extreme caution should be used when considering dilation of irregular, non-compliant tissue or in the presence of certain calculi.This is a single use device.Do not resterilize 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 device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: this device should be used only by a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract.Directions for use: catheter insertion prior to use, carefully inspect the catheter for bends, kinks, or other damage which may have occurred during shipment.Do not use the product if damage is evident.Dilation procedures may be conducted under fluoroscopic guidance with appropriate x-ray equipment or by direct vision.Endoscopically place a 0.038¿ (.97mm) diameter guidewire with the flexible end in the renal pelvis.Remove the protective balloon sheath and stylet from the catheter.Advance the catheter over the guidewire.Use the radiopaque markers located under the balloon to aid in positioning.Catheter balloon inflation: confirm proper placement of the balloon within the urinary tract.Inflate the balloon with standard inflation medium (e.G., diatrizoate meglumine injection u.S.P.60% diluted as appropriate) using a 10cc or larger syringe or inflation device.Note: do not use air or any gaseous substance as a balloon inflation medium.Note: the use of an inflation device to monitor balloon pressure is strongly recommended to determine that adequate pressure is applied and that maximum limits of the balloon are not exceeded.Caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to reinflate the balloon.If, upon inspection of the balloon, it is noted that pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible.Catheter balloon deflation and removal: deflate the balloon using a 10cc or larger syringe or inflation device.Since deflation times vary with balloon sizes and shaft lengths, check fluoroscopically to confirm deflation before attempting withdrawal.Remove the syringe or inflation device from the catheter allowing ambient pressure to relax the balloon.Gently withdraw the catheter.As the balloon starts to exit the endoscope use a smooth, gentle, steady counterclockwise motion to facilitate withdrawal.Caution: if resistance is felt when either removing the guidewire from the catheter or the catheter from the endoscope, stop and consider removing them as a single unit to prevent damage to the product or tissue trauma.Applying excessive force to the catheter can result in tip breakage or balloon separation.Warning: after use, the uroforce balloon dilation catheter and/or accessories may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Store in a cool, dry place.Do not expose to organic solvents, temperatures in excess of 85°c or steam." (b)(4).

Event Description

It was reported that a piece of the catheter balloon came off in the patient during surgery.The complainant alleges that the piece was removed before surgery was completed.No patient injury was reported.

• Brand Name: UROFORCE® BALLOON DILATION CATHETER
• Type of Device: DILATION KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6639240
• MDR Text Key: 77614631
• Report Number: 1018233-2017-03117
• Device Sequence Number: 1
• Product Code: EZN
• UDI-Device Identifier: 10801741053006
• UDI-Public: (01)10801741053006(10)GFAR1730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 887604
• Device Catalogue Number: 887604
• Device Lot Number: GFAR1730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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