MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) -1313046 POLYURETHANE DISPOSABLE URETERAL CATHETER

Catalog Number 136505

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

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 the device allegedly broke into several pieces when it was being removed from the patient.Since the device broke into several pieces upon removal it required the physician to remove each piece from the patient individually as they broke.The physician placed a stent in the patient upon removal of the catheter.

Manufacturer Narrative

The physical sample was not returned for evaluation however a photo of the sample was provided.Based on the photos received, the complaint was confirmed for the catheter breaking into pieces.The expiration date and manufacturing date for this device is not known as the device history record could not be reviewed.According to the lot number the device was packaged around october of 1976.The device was manufactured prior to1990 and was used well beyond its shelf life; therefore, a dhr review could not be performed.A 5-year expiration date was placed on these products between 1991 and 1993.The complaint was confirmed according to the photo provided with an unknown root cause.The instructions for use state the following: "indications for use: the bard polyurethane ureteral catheters are intended for use in the drainage of urine from the ureter.The polyurethane ureteral catheter is inserted through the urethra, into the bladder and up through the ureter.These catheters also allow the delivery of contrast media.Directions for use: ureteral catheters are designed in a variety of distal tip configurations.The anatomical characteristics of the ureteral orifice and physician preference should determine the choice of design in a specific clinical situation.Closed tip placement (placed without a guidewire) after placement of the cystoscope into the bladder, the ureteral orifice is located and examined and a choice of ureteral catheter is made.The catheter adapter is secured to the ureteral catheter, and the catheter is flushed to evacuate all air bubbles.Under direct vision, the catheter tip is positioned within the ureteral orifice.Contrast media is then injected through the ureteral catheter into the ureter.Under fluoroscopy, the ureter is visualized and required intervention determined.Open tip placement (placed with a guidewire).After placement of the cystoscope into the bladder, the ureteral orifice is located and examined and a choice of ureteral catheter is made.Under direct vision, the guidewire is positioned within the ureteral orifice.The ureteral catheter is inserted over the guidewire and advanced into the ureter.The guidewire is removed and the catheter adapter is secured to the catheter.Gentle aspiration to evacuate air from the catheter can be performed at this time.Contrast media is then injected through the ureteral catheter into the ureter.Under fluoroscopy, the ureter is visualized and required intervention determined.Warning: this unit should not be used as a ureteral splint.Caution: do not withdraw ureteral catheter while it is deflected in endoscope.Avoid sharp bending.Caution: do not over-tighten the catheter adapter.Over-tightening the catheter adapter may occlude the lumen of the catheter.Caution: when using the tigertail's catheter without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force is made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible portion of the catheter become detached, retrieve with an endourology grasping device." (b)(4).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.Device not returned.

• Brand Name: POLYURETHANE DISPOSABLE URETERAL CATHETER
• Type of Device: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO) -1313046; 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO) -1313046; 289 bay road; queensbury NY 12804
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5194409
• MDR Text Key: 30502146
• Report Number: 1018233-2015-00431
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136505
• Device Lot Number: AJ71636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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