MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH; PROXIS ACCESS SHEATH

Model Number 231235

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 inner lumen was scraping off during the procedure.There was, allegedly, no impact to the patient and the same device was used throughout the treatment.

Manufacturer Narrative

The reported event was confirmed, as use related.Evaluation of the sample noted that something scraped the inner liner and peeled back a portion of the liner, resulting in a mark that is about 10cm and runs lengthwise inside the device.No other delamination was noted.The inner liner was damaged during use by coming into contact with a sharp object.The user either pulled too large of a stone through the sheath and/or the stone was sharp, or used a scope that had burrs or sharp edges that damaged the liner.A potential root cause provided by futurematrix was that the mandrel used in manufacturing could have damaged the liner.However, the in-house mandrels were inspected and no burrs were found on them.Liners are 100% inspected during assembly to ensure any damaged units are identified and isolated.A statement was added to the manufacturing description indicating that the operators are to inspect the mandrels for burrs or any sharp edges.Based on the investigation findings, current manufacturing controls were considered adequate as to detect and segregate any nonconforming unit.Event described could not be confirmed as a manufacturing related issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿description: the proxis¿ ureteral access sheath is a two component ureteral dilation system which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments.The packaged product includes the following items: 1 - hydrophilic-coated dilator with female luer connector, 1 - hydrophilic-coated sheath with hub.Indications for use: the proxis¿ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Contraindications: ¿ patients who are contraindicated for retrograde urological procedures.¿ patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticogagulations.¿ patients who have the presence of tight strictures which would limit use of the device.¿ patients who have the presence of large obstructing distal ureteral calculi.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events potential adverse events associated with the use of the transurethral access device include, but are not limited to: - mucosal irritation, inflammation and edema - urethral strictures - acute bleeding or hemorrhage - urethral, bladder, or ureteral perforation - other injury to the urinary tract directions for use: activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035" (0.889mm) or 0.038" (0.965mm) guidewire into the ureter using standard endourology techniques.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.While maintaining sheath position, disengage the dilator lock from the sheath hub to gently remove the dilator.Do not advance sheath without the dilator in place.Note: suture holes are provided on sheath hub for securing externally, if desired.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.If desired, irrigation can be applied using the luer connector on the dilator.Upon completion of the access procedure, gently withdraw the device.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only" (b)(4).

Event Description

It was reported that the inner lumen was scraping off during the procedure.There was, allegedly, no impact to the patient and the same device was used throughout the treatment.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Type of Device: PROXIS ACCESS SHEATH
• 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: 6540258
• MDR Text Key: 74413458
• Report Number: 1018233-2017-02254
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00801741101717
• UDI-Public: (01)00801741101717(17)190909(10)BMAVFM39
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2019
• Device Model Number: 231235
• Device Catalogue Number: 231235
• Device Lot Number: BMAVFM39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2016
• 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