MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® POLYURETHANE URETERAL CATHETERS, OPEN TIP

Catalog Number 134005

Device Problems Incorrect Measurement (1383); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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.The device was not returned.

Event Description

It was reported that the urethral catheter seemed slightly larger than usual, which made it difficult to pass through the ureter.The complainant reportedly used a 0.035 guide wire with the catheter.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿catheter diameter incorrect¿.A potential root cause for this failure could be ¿catheter outer diameter too large¿.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: "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¿ 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." 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.

Event Description

It was reported that the urethral catheter seemed slightly larger than usual, which made it difficult to pass through the ureter.The complainant reportedly used a 0.035 guide wire with the catheter.

• Brand Name: BARD® POLYURETHANE URETERAL CATHETERS, OPEN TIP
• Type of Device: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8577487
• MDR Text Key: 144129188
• Report Number: 1018233-2019-02299
• Device Sequence Number: 1
• Product Code: EYB
• 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: 06/03/2019

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: 134005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1