BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 5799772 · Received July 15, 2016

    Report

    Report Number
    1820334-2016-00710
    Event Type
    Injury
    Date Received
    July 15, 2016
    Report Date
    May 10, 2016
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), DOCUMENTATION, SPECIFICATIONS, AND TRENDS OF THE PRODUCT WAS CONDUCTED. THE COMPLAINT DEVICE WAS NOT RETURNED. THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE IFU CAUTIONS THAT THERE HAVE BEEN DOCUMENTED COMPLICATIONS WITH URETERAL STENT PLACEMENT. THE USE OF URETERAL STENTS SHOULD CONSIDER THE RISK-BENEFIT FACTORS AS APPLICABLE TO THE PATIENT. BASED UPON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR # 1820334-2016-00402 ORIGINALLY SENT ON 07 JUNE 2016, AND WAS CREATED TO CAPTURE THE EVENTS OF CASE 4 OUT OF THE 5 CASES INDICATED IN THE LITERATURE ATTACHED. CASE 1: MDR# 1820334-2016-00402, CASE 2: MDR# 1820334-2016-00708, CASE 3: MDR# 1820334-2016-00709, CASE 5: MDR# 1820334-2016-00711. AS STATED IN THE JOURNAL ARTICLE "KNOTTED PROXIMAL LOOP OF URETERIC STENTS: REVIEW OF THE LITERATURE AND FIVE CASE REPORTS", NARIMAN AHMADI, MINH TRAN, MARTIN ELMS AND RAMOND K; JOURNAL OF CLINICAL UROLOGY 1-6 ( 2014): "A (B)(6) MALE PRESENTED FOR AN ELECTIVE ROUTINE CHANGE OF BILATERAL URETERIC STENTS FOR RETROPERITONEAL FIBROSIS SECONDARY TO TREATED LYMPHOMA. ALTHOUGH THE PATIENT WAS ON PERITONEAL DIALYSIS, HE STILL PRODUCED AROUND TWO LITERS OF URINE PER DAY. INTRAOPERATIVE ATTEMPTS TO RE-WIRE THE RIGHT-SIDED STENT (7 FR DOUBLE J. MULTI-LENGTH STIFF, COOK UROLOGICAL INC, (B)(4)) WERE UNSUCCESSFUL ONCE AGAIN SECONDARY TO MILD ENCRUSTATION WITHIN THE STENT LUMEN N REMOVAL OF THE STENT BY GENTLE TRACTION, A TIGHT KNOT WAS FORMED AND THE STENT BECAME STUCK AT THE LEVEL OF THE SACRO-ILIAC JOINT. A RIGID URETEROSCOPE WAS INTRODUCED AND HOLMIUM LASER WAS USED TO LASER THE KNOT AS PREVIOUSLY DESCRIBED IN CASES I AND 2. HOWEVER, BECAUSE OF THE NARROW CALIBER OF THE URETER, WE WERE UNABLE TO LASER THE KNOT ITSELF. THE REMAINING PROXIMAL KNOTTED STENT FRAGMENT WAS PUSHED BACK UP TOWARD THE KIDNEY AND SUBSEQUENT FLEXIBLE PYELOSCOPY WAS ATTEMPTED. UNFORTUNATELY THIS WAS ALSO UNSUCCESSFUL SECONDARY TO THE NARROW CALIBER OF THE URETER (MDR# 1820334-2016-00709). AS A RESULT, A NEW STENT WAS INSERTED (7 FR DOUBLE J, MULTI LENGTH STIFF, COOK UROLOGICAL INC, (B)(4)) AND THE PROXIMAL KNOTTED STENT FRAGMENT WAS LEFT IN SITU. THE STENT FRAGMENT WAS SUBSEQUENTLY RETRIEVED PERCUTANEOUSLY AT A LATER DATE. THE ATTEMPT TO CHANGE THE CONTRALATERAL STENT (7 FR DOUBLE J, MULTI-LENGTH STIFF, COOK UROLOGICAL INC, (B)(4)) WAS ALSO ABANDONED WHEN PREOPERATIVE IMAGING NOTED AN ALREADY FORMED PROXIMAL KNOT. THE STENT WAS LEFT IN SITU AND CHANGED PERCUTANEOUSLY AT A LATER DATE. (MDR# 1820334-2016-00710)." NO COMPLICATIONS WERE OBSERVED POST-OPERATIVE HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR # 1820334-2016-00402 ORIGINALLY SENT ON 07 JUNE 2016, AND WAS CREATED TO CAPTURE THE EVENTS OF CASE 4 OUT OF THE 5 CASES INDICATED. CASE 1: MDR# 1820334-2016-00402; CASE 2: MDR# 1820334-2016-00708; CASE 3: MDR# 1820334-2016-00709; CASE 4: MDR# 1820334-2016-00710 (SUBJECT OF THIS REPORT); CASE 5: MDR# 1820334-2016-00711. AS STATED IN THE JOURNAL ARTICLE "KNOTTED PROXIMAL LOOP OF URETERIC STENTS: REVIEW OF THE LITERATURE AND FIVE CASE REPORTS", NARIMAN AHMADI, MINH TRAN, MARTIN ELMS AND RAMOND K; JOURNAL OF CLINICAL UROLOGY 1-6 ( 2014): "A (B)(6) MALE PRESENTED FOR AN ELECTIVE ROUTINE CHANGE OF BILATERAL URETERIC STENTS FOR RETROPERITONEAL FIBRO­ SIS SECONDARY TO TREATED LYMPHOMA. ALTHOUGH THE PATIENT WAS ON PERITONEAL DIALYSIS, HE STILL PRODUCED AROUND TWO LITERS OF URINE PER DAY. INTRAOPERATIVE ATTEMPTS TO RE-WIRE THE RIGHT-SIDED STENT (7 FR DOUBLE J. MULTI!ENGTH STIFF, (B)(4)) WERE UNSUCCESSFUL ONCE AGAIN SECONDARY TO MILD ENCRUSTATION WITHIN THE STENT LUMEN N REMOVAL OF THE STENT BY GENTLE TRACTION, A TIGHT KNOT WAS FORMED AND THE STENT BECAME STUCK AT THE LEVEL OF THE SACRO-ILIAC JOINT. A RIGID URETEROSCOPE WAS INTRODUCED AND HOLMIUM LASER WAS USED TO LASER THE KNOT AS PREVIOUSLY DESCRIBED IN CASES I AND 2. HOWEVER, BECAUSE OF THE NAR­ROW CALIBER OF THE URETER, WE WERE UNABLE TO LASER THE KNOT ITSELF. THE REMAINING PROXIMAL KNOTTED STENT FRAGMENT WAS PUSHED BACK UP TOWARD THE KIDNEY AND SUBSEQUENT FLEXIBLE PYELOSCOPY WAS ATTEMPTED. UNFORTUNATELY THIS WAS ALSO UNSUCCESSFUL SECONDARY TO THE NARROW CALIBER OF THE URETER (MDR# 1820334-2016-00709). AS A RESULT, A NEW STENT WAS INSERTED (7 FR DOUBLE J, MULTI­ LENGTH STIFF, (B)(4)) AND THE PROXIMAL KNOTTED STENT FRAGMENT WAS LEFT IN SITU. THE STENT FRAGMENT WAS SUBSEQUENTLY RETRIEVED PERCUTANEOUSLY AT A LATER DATE. THE ATTEMPT TO CHANGE THE CONTRALATERAL STENT (7 FR DOUBLE J, MULTILENGTH STIFF, (B)(4)) WAS ALSO ABANDONED WHEN PRE­OPERATIVE IMAGING NOTED AN ALREADY FORMED PROXIMAL KNOT (FIGURE 5). THE STENT WAS LEFT IN SITU AND CHANGED PERCUTANEOUSLY AT A LATER DATE. (MDR# 1820334-2016-00710)." NO COMPLICATIONS WERE OBSERVED POST-OPERATIVE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451197 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other