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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETERAL STENTS; UNKNOWN INLAY URETERAL STENT W/ HYDROGLIDE GUIDEWIRE
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C.R. BARD, INC. (COVINGTON) -1018233 URETERAL STENTS; UNKNOWN INLAY URETERAL STENT W/ HYDROGLIDE GUIDEWIRE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Injury (2348); Impaired Healing (2378); 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 inlay ureteral stent did not perform as intended.The respondent said "ureterverletzung geschient, diese ist nicht ausgeheilt", roughly translated to ""ureteral injury splinted, this has not healed.".
 
Event Description
It was reported that the inlay ureteral stent did not perform as intended.The respondent said "ureterverletzung geschient, diese ist nicht ausgeheilt", roughly translated to "ureteral injury splinted, this has not healed".
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿incompatible accessories/or undesirable 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.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿loose foreign matter or engraved greater than 0.3mm2¿ with a potential root cause of ¿defective components from supplier/ with contamination or no follow up to production areas cleaning procedure¿.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.
 
Event Description
It was reported that the inlay ureteral stent did not perform as intended.The respondent said "ureterverletzung geschient, diese ist nicht ausgeheilt", roughly translated to "ureteral injury splinted, this has not healed".
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿incompatible accessories/or undesirable 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.
 
Event Description
It was reported that the inlay ureteral stent did not perform as intended.Tthe respondent said "ureterverletzung geschient, diese ist nicht ausgeheilt", roughly translated to ""ureteral injury splinted, this has not healed".It was later reported via email on 12jun2020 from the regional contact (ibc), the user reported the device was removed and discarded.
 
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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 Key9753330
MDR Text Key188330296
Report Number1018233-2020-01342
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K983498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,study
Type of Report Initial,Followup,Followup,Followup
Report Date 06/25/2020
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received03/12/2020
03/30/2020
06/12/2020
Supplement Dates FDA Received03/19/2020
04/20/2020
06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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