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

Model Number 231045

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the while doing a cystoscopy, right ureteroscopy with laser holmium the ureteral access sheath started to peel/shear apart inside the sheath.Increased operating room time in order to withdraw the foreign body.

Event Description

It was reported that the while doing a cystoscopy, right ureteroscopy with laser holmium the ureteral access sheath started to peel/shear apart inside the sheath.Increased operating room time in order to withdraw the foreign body.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.A potential root cause for this event is material selection.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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 or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action." "do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action." correction: e h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16503025
• MDR Text Key: 310907757
• Report Number: 1018233-2023-01541
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 231045
• Device Catalogue Number: 231045
• Device Lot Number: BMGPFM12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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
• Patient Outcome(s): Other