MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETERAL STENTS; UNKNOWN INLAY URETERAL STENT W/ HYDROGLIDE GUIDEWIRE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 user faced unexpected challenges while using the inlay ureteral stent product."perforatuion des harnleiters", roughly translated to "perforation of the ureter".

Event Description

It was reported that the user faced unexpected challenges while using the inlay ureteral stent product."perforatuion des harnleiters", roughly translated to "perforation of the ureter".

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿damaged (break, kink or coating compromised) or compromised function¿ with a potential root cause of ¿user related(see use error potential cause of failure column)¿.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard/bd is unable to determine the associated labeling to review.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.H3 other text : the device was not returned.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿product damaged in transit¿ with a potential root cause of ¿inadequate packaging design¿.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard/bd is unable to determine the associated labeling to review.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.The device was not returned.

Event Description

It was reported that the user faced unexpected challenges while using the inlay ureteral stent product."perforation des harnleiters", roughly translated to "perforation of the ureter".

• Brand Name: URETERAL STENTS
• Type of Device: UNKNOWN INLAY URETERAL STENT W/ HYDROGLIDE GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9753230
• MDR Text Key: 187685882
• Report Number: 1018233-2020-01340
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/12/2020; 03/27/2020
• Supplement Dates FDA Received: 03/19/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other