MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 APTRA SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE

Catalog Number BDRD01

Device Problem Material Fragmentation (1261)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that the aptrascope was punctured and went through a patient's ureter.Doctor thought it was because the women had a lot of infections within their renal system.Medical intervention was unknown.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the aptrascope was punctured and went through a patient's ureter.Doctor thought it was because the women had a lot of infections within their renal system.Medical intervention was unknown.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be loss of articulation.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "troubleshooting: problem: loss of articulation.Cause: articulation wires have been stretched or broken.Solution: dispose of the ureteroscope and replace with a new one.Problem: angulation feels stiff.Cause: damaged deflection section causing impaired angulation.Solution: dispose of the ureteroscope and replace with a new one.Problem: angulation alignment is no longer up or down.Cause: insertion tube has become twisted.Solution: dispose of the ureteroscope and replace with a new one.Warning: do not apply excessive force to the articulation lever when the distal tip is hindered by obstacles.Doing so may damage the control mechanism or cause injury to the patient.Warning: do not force the flexible tip into a straight or flexed position while holding the articulation lever.Doing so can damage the control mechanism.Warning: if you encounter resistance when advancing or withdrawing an accessory through the ureteroscope, visually confirm that the tip of the ureteroscope is not in contact with tissue.Ensure the articulation lever is in the neutral position so that the distal tip of the ureteroscope is in a straight, non-articulated position." 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: APTRA SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE
• Type of Device: APTRA SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 17435732
• MDR Text Key: 320151366
• Report Number: 1018233-2023-05691
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BDRD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2023
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female