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

Model Number	231045
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed, as cause unknown.Evaluation report of the returned sample, submitted by futurematrix interventional, stated that when a stylus light was used to look inside of the sheath for any defects, a horizontal scratch was noticed measuring approximately 2mm in length at approximately half way down the shaft.A second scratch was noticed vertically measuring approximately 5-6mm in length as well.The liner appeared to be intact with 2 small scratches.Burr on mandrels was considered a potential root cause, however was ruled out due to all mandrels being 100% inspected for any burrs or sharp edges prior to use.Sheath liner was 100% inspected under darkened room lighting using a stylus light.Personnel were verified to be trained to the manufacturing instructions.Futurematrix interventional concluded that the root cause cannot be determined due to the unknown size of the kidney stone being removed.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: 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.".
Event or Problem Description
It was reported that there was an unidentifiable thread found during the case, from the sheath.The doctor has inquired on what the material may be.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that there was an unidentifiable thread found during the case, from the sheath.The doctor has inquired on what the material may be.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9125858
• Report Number: 1018233-2019-06002
• Device Sequence Number: 380677
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 231045
• Device Catalogue Number: 231045
• Device Lot Number: BMDRFM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1