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

Model Number 231225

Device Problems Difficult to Insert (1316); Misassembled (1398)

Patient Problems No Consequences Or Impact To Patient (2199); 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 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 hole of the funnel part of the proxis access sheath was too small in diameter, causing the inner sheath to get caught when it was being inserted about an inch from the tip.No patient impact reported.

Manufacturer Narrative

The reported event was unconfirmed.Evaluation of the returned sample, submitted by futurematrix interventional, stated that when the dilator was re-inserted into the sheath to check for any resistance, resistance was felt but dilator did transition into sheath.The dimensional evaluation indicates that both the sheath and the dilator meet specifications.The report also states that all dhr's were reviewed, parts meet specification requirements at initial qc check and no errors were found.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "directions for use: 1.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.2.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.3.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.4.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.5.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.6.If desired, irrigation can be applied using the luer connector on the dilator.7.Upon completion of the access procedure, gently withdraw the device.8.Discard the device in accordance with hospital procedures and with applicable laws and regulations." h11: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 hole of the funnel part of the proxis access sheath was too small in diameter, causing the inner sheath to get caught when it was being inserted about an inch from the tip.No patient impact reported.

• 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
• MDR Report Key: 8775847
• MDR Text Key: 150698705
• Report Number: 1018233-2019-03778
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00801741101700
• UDI-Public: (01)00801741101700
• Combination Product (y/n): N
• PMA/PMN Number: K160861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: 231225
• Device Catalogue Number: 231225
• Device Lot Number: BMCXFM04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Date Manufacturer Received: 09/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1