MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETERAL STENTS

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

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 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 there was a difference in the instructions for use (ifu) of the inlay stent and inlay optima stent.It was stated that for the inlay optima, an indwelling time up to 365 days was mentioned in the ifu.However, the indwelling time for inlay optima stent was not mentioned in the ifu.The same difference was observed in the bd website also, for the inlay optima, an ¿indwelling time of up to 365 days¿ was mentioned on the website.For the inlay, the 365 days limit was not mentioned on the website.The stent comes individually packaged in a single use, sterile configuration.Only in the brochure that was sent to the customer, it was mentioned as ¿when long-term use is indicated, it is recommended that indwelling time not exceed 365 days¿.Also, the customer stated that as per research paper (aravantinos e, gravas s, karatzas ad, et al.Forgotten, encrusted ureteral stents: a challenging problem with an endourologic solution.Journal of endourology.The literature warns that for urinary stones usage, ¿it has been reported that a period between 2 and 4 months can be considered optimal.However, patients with recurrent encrustations on stents should have them changed earlier (every 6¿8 weeks).¿ the customer stated that the representative's plain recommendation, for the inlay optima, of an indwelling time up to 365 days ¿ without any clinical evidence in humans was surprising and without reservation and could place them at risk for litigation.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "incorrect/ missing translation; missing instructions; vendor/printer error.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Correction: g h11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that there was a difference in the instructions for use (ifu) of the inlay stent and inlay optima stent.It was stated that for the inlay optima, an indwelling time up to 365 days was mentioned in the ifu.However, the indwelling time for inlay optima stent was not mentioned in the ifu.The same difference was observed in the bd website also, for the inlay optima, an ¿indwelling time of up to 365 days¿ was mentioned on the website.For the inlay, the 365 days limit was not mentioned on the website.The stent comes individually packaged in a single use, sterile configuration.Only in the brochure that was sent to the customer, it was mentioned as ¿when long-term use is indicated, it is recommended that indwelling time not exceed 365 days¿.Also, the customer stated that as per research paper (aravantinos e, gravas s, karatzas ad, et al.Forgotten, encrusted ureteral stents: a challenging problem with an endourologic solution.Journal of endourology.The literature warns that for urinary stones usage, ¿it has been reported that a period between 2 and 4 months can be considered optimal.However, patients with recurrent encrustations on stents should have them changed earlier (every 6¿8 weeks).¿ the customer stated that the representative's plain recommendation, for the inlay optima, of an indwelling time up to 365 days ¿ without any clinical evidence in humans was surprising and without reservation and could place them at risk for litigation.

• Brand Name: URETERAL STENTS
• Type of Device: URETERAL STENTS
• 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: 15798906
• MDR Text Key: 307685767
• Report Number: 1018233-2022-08762
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/24/2023
• 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