MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE; DILATION CATHETER

Model Number 021312

Device Problems Incorrect Measurement (1383); Dull, Blunt (2407); Structural Problem (2506)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

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 tip was very blunt instead of having a smooth tapered end.The patient alleged significant damage to the urethral tissue.There was no change in the medical management of a patient that has a more traumatic dilation (damage to urethral tissue), except to leave the post-dilation catheter in longer.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.The condition of the sample received was unopened and unused.The visual evaluation of the sample noted no obvious defects such as cracks or lumps.Per the dimensional evaluation, the tapered end of the product did not meet specifications.The tip of the device was unable to pass through french size 11 as required.The tapered feature was not present.A potential root cause of the reported event was that the french size tip mold was too big due to operator error or machine error.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: "1.Bard® heyman¿ followers are intended to be used with bardex® councill catheters and bard® heyman¿ filiform catheters.All individual devices are disposable and sold sterile.2.The filiform catheter comes packaged with a disposable stylet to use for insertion.Insert the bard® heyman¿ filiform catheter with stylet in place.The filiform catheter may be placed by inserting through a cystoscope under direct vision.Direct view catheter placement will decrease the number of difficult and possible false passages.3.There is a 3 centimeter orientation marking on the filiform catheter at 30 centimeters from the distal end to assist with placing the filiform catheter in the bladder.Placement of the filiform catheter in the bladder can be determined by removing the stylet and observing urine or aspirating urine with a syringe.If added confirmation is necessary, a radio graph can be taken after injecting radiopaque dye into the filiform catheter.When the filiform catheter has been properly placed, the stylet should be discarded.4.Starting with the smaller sizes, slip the bard® heyman¿ followers (straight or coude) over the filiform catheter.Increase the follower size until the desired dilation is accomplished.5.Slip a bardex® councill catheter over the filiform catheter and when it is in place, inflate balloon.Remove the filiform catheter.If, at a later time, the councill catheter is to be replaced, insert a new filiform catheter prior to removing the councill catheter.The filiform catheter will then guide the new councill catheter into place.After use, this product may be potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: because the filiform catheter may advance with the passage of the followers, a length of the filiform catheter should always appear beyond the proximal end of the follower, otherwise the filiform catheter may be left in the urethra when the follower is withdrawn.".

Event Description

It was reported that the tip was very blunt instead of having a smooth tapered end.The patient alleged significant damage to the urethral tissue.There was no change in the medical management of a patient that has a more traumatic dilation (damage to urethral tissue), except to leave the post-dilation catheter in longer.

• Brand Name: BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE
• Type of Device: DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7519796
• MDR Text Key: 108451607
• Report Number: 1018233-2018-01778
• Device Sequence Number: 1
• Product Code: FBW
• UDI-Device Identifier: 00801741075605
• UDI-Public: (01)00801741075605
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 021312
• Device Catalogue Number: 021312
• Device Lot Number: MCBV6209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other