MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DILATION PRODUCTS

Catalog Number UNKNOWN

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a female patient had a percutaneous nephrostolithotomy where an x-force nephrostomy balloon dilating catheter was used on (b)(6) 2018.A ct scan on (b)(6) 2018 was being completed for other medical reasons not related.The scan revealed a foreign body which was asymptomatic to the patient and was a coincidental finding on ct scan.A ureteroscopy showed what appeared to be part of a sheath measuring 7x7mm which was not collapsible or foldable and could not be removed during the ureteroscopy.The foreign body was removed percutaneously.A double-j stent and foley catheter was left in place after the foreign body removal.The patient was admitted on (b)(6) 2018 as a 23 hour observation patient, post foreign body removal and started on cephalexin 500 mg by mouth three times a day and continued on the same antibiotic at discharge from hospital admission.The pathology report gross examination of the foreign object was as follows, "it is a 0.9 x 0.6 x 0.1 cm curvilinear portion of plastic having a lime green colored outer diameter and a tan-light blue colored inner diameter.".

Event Description

It was reported that a female patient had a percutaneous nephrostolithotomy where an x-force nephrostomy balloon dilating catheter was used on (b)(6)2018.A ct scan on (b)(6)2018 was being completed for other medical reasons not related.The scan revealed a foreign body which was asymptomatic to the patient and was a coincidental finding on ct scan.A ureteroscopy showed what appeared to be part of a sheath measuring 7x7mm which was not collapsible or foldable and could not be removed during the ureteroscopy.The foreign body was removed percutaneously.A double-j stent and foley catheter was left in place after the foreign body removal.The patient was admitted on (b)(6)2018 as a 23 hour observation patient, post foreign body removal and started on cephalexin 500 mg by mouth three times a day and continued on the same antibiotic at discharge from hospital admission.The pathology report gross examination of the foreign object was as follows, "it is a 0.9 x 0.6 x 0.1 cm curvilinear portion of plastic having a lime green colored outer diameter and a tan-light blue colored inner diameter.".

Manufacturer Narrative

The physical sample was not returned for evaluation.An image was submitted for evaluation.The lot number and product catalog number were not provided.However, the complainant indicated that the patient had undergone a nephrostomy procedure.Evaluation of the medical image depicted an inorganic material retained in the body of the imaged patient.The color of the image was clear and the material was determined to be lime green as reported by the complainant.The alleged tan-light blue colored inner diameter of the material could not be confirmed without evaluating the physical sample.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿description the x-force® nephrostomy balloon dilation catheter is a dual lumen catheter with a 24 (8mm) or 30fr (10mm) balloon mounted on the distal tip.It has a radiopaque tip and a radiopaque marker beneath the balloon.The lumen labeled with rated burst pressure (xx atm) 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 the 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 dilation catheter comes packaged with a refolding tool and a working sheath.It is available with or without an inflation device.It comes sterile and is for single use only.Indications for use the x-force® nephrostomy balloon dilation catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.Contraindications do not use the x-force® nephrostomy balloon dilation catheter in the presence of conditions which create unacceptable risk during the dilation of the nephrostomy tract.Warnings: ¿ if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation.¿ do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.¿ 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: ¿ only a physician who has an understanding of the clinical applications, technical principles and associated risks associated with balloon dilation of the nephrostomy tract should use this device.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable laws and regulations.Potential complications the complications that may arise from a balloon dilation procedure include tissue trauma and perforation.Inspection prior to use the x-force® nephrostomy balloon dilation catheter is a sterile, single 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.Preparation of the catheter all x-force® nephrostomy balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter 4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen." patient code: (b)(4).

• Brand Name: DILATION PRODUCTS
• Type of Device: DILATION PRODUCTS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8189743
• MDR Text Key: 131166750
• Report Number: 1018233-2018-06135
• Device Sequence Number: 1
• Product Code: FBW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention