RESONANCE STENT SET
Report
- Report Number
- 3001845648-2020-00140
- Event Type
- Injury
- Date Received
- March 3, 2020
- Date of Event
- October 8, 2019
- Report Date
- July 6, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- UDI-DI
- 10827002341118
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 AFTER THE INVESTIGATION WAS COMPLETED AS FOLLOWS: AS THE DEVICES HAVE NOT BEEN RETURNED TO CIRL FOR EVALUATION, IS IT NOW UNLIKELY THAT THEM WILL BE RETURNING? CAN YOU PLEASE CONFIRM? I HAVE CHECKED IN A NUMBER OF TIMES BUT NEVER GET A CLEAR ANSWER SO I¿M NOT SURE UNFORTUNATELY THE FIRST REMOVAL WAS ATTEMPTED ON THE (B)(6) 2019, WHY WAS NEXT ATTEMPT AT REMOVAL NOT UNTIL THE (B)(6) 2020? THE PATIENT HAD TO BE PERC¿D AND DUE TO SCHEDULING CONFLICTS/ISSUES THIS WAS THE FIRST AVAILABLE WHAT WAS THE PATIENT'S CONDITION DURING THIS TIME? STABLE. WERE THE STENTS PROVIDING DRAINAGE DURING THIS PERIOD? BILATERAL NEPHROSTOMY TUBES WAS ANY DAMAGE OR ENCRUSTATION NOTED ON THE STENT WHEN REMOVED ON THE 04 FEB 2020? ENCRUSTED ON BOTH. ALSO I NOTE THE STENTS APPEAR TO HAVE BEEN PLACED ON (B)(6) 2018. "HOW LONG WAS THE STENT IN-DWELLING? -(B)(6) 2018 TO (B)(6) 2020" IS THAT CORRECT? INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
1 X RMS-060026-R OF LOT NUMBER C1477851 WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. THEREFORE A DOCUMENT BASED INVESTIGATION WAS COMPLETED. THIS INVESTIGATION FILE (B)(4) CAPTURES THE STENT OF LOT NUMBER C1477851 PLACED ON THE RIGHT SIDE REMOVED IN THE PATIENT. THE INVESTIGATION FILE (B)(4) IS LINKED TO THIS FILE AND CAPTURES THE INVESTIGATION INTO THE STENT OF LOT NUMBER C1484934 PLACED ON THE LEFT SIDE. PRIOR TO DISTRIBUTION RMS-060026-R DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL . A REVIEW OF THE MANUFACTURING RECORDS FOR RMS-060026-R OF LOT NUMBER C1477851 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1477851 . IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿WARNINGS: THESE STENTS ARE NOT INTENDED AS PERMANENT INDWELLING DEVICES. THE STENT MUST NOT REMAIN INDWELLING MORE THAN TWELVE (12) MONTHS. IF THE PATIENT¿S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT. PATIENTS SHOULD BE CHECKED AT REGULAR INTERVAL UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENT USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE¿ IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED THAT ¿THE STENT MAY BE REMOVED USING CONVENTIONAL CYSTOSCOPIC TECHNIQUES UTILIZING FORCEPS OR GRASPER. NOTE: DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE PHYSICIAN TO THE USER LEAVING THE STENTS IN PLACE FOR LONGER THAN THE RECOMMENDED INDWELL TIME AND/OR DIFFICULT PATIENT ANATOMY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE STENTS WERE LEFT INDWELLING FOR 16 MONTHS. THE IFU INSTRUCTS THAT THE STENT SHOULD NOT REMAIN IN PLACE FOR MORE THAN 12 MONTHS. THE FAILED EXCHANGE OCCURRED ON THE 8TH OF OCTOBER 2019 AND THE EXPLANT THEN OCCURRED ON THE(B)(6) 2020. THIS INCREASE IN INDWELL TIME COULD HAVE RESULTED IN EITHER STENT ENCRUSTATION OR TISSUE INGROWTH, INHIBITING ITS REMOVAL AS A RESULT OF THIS EXTENDED DWELL TIME. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A SECOND PROCEDURE WAS REQUIRED TO REMOVE THE STENTS AND THERE WAS INCREASED STONE FORMATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
RELATED TO MDR REF# 3001845648-2020-00139. 1 X RMS-060026-R OF LOT NUMBER C1477851 WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. THEREFORE A DOCUMENT BASED INVESTIGATION WAS COMPLETED. THIS INVESTIGATION FILE (B)(4) CAPTURES THE STENT OF LOT NUMBER C1477851 PLACED ON THE RIGHT SIDE REMOVED IN THE PATIENT. THE INVESTIGATION FILE (B)(4) IS LINKED TO THIS FILE AND CAPTURES THE INVESTIGATION INTO THE STENT OF LOT NUMBER C1484934 PLACED ON THE LEFT SIDE. PRIOR TO DISTRIBUTION RMS-060026-R DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL A REVIEW OF THE MANUFACTURING RECORDS FOR RMS-060026-R OF LOT NUMBER C1477851 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1477851. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿WARNINGS: THESE STENTS ARE NOT INTENDED AS PERMANENT INDWELLING DEVICES. THE STENT MUST NOT REMAIN INDWELLING MORE THAN TWELVE (12) MONTHS. IF THE PATIENT¿S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT. PATIENTS SHOULD BE CHECKED AT REGULAR INTERVAL UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENT USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE.¿ IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED THAT ¿THE STENT MAY BE REMOVED USING CONVENTIONAL CYSTOSCOPIC TECHNIQUES UTILIZING FORCEPS OR GRASPER. NOTE: DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE PHYSICIAN TO THE USER LEAVING THE STENTS IN PLACE FOR LONGER THAN THE RECOMMENDED INDWELL TIME AND/OR DIFFICULT PATIENT ANATOMY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE STENTS WERE LEFT INDWELLING FOR 16 MONTHS. THE IFU INSTRUCTS THAT THE STENT SHOULD NOT REMAIN IN PLACE FOR MORE THAN 12 MONTHS. THE FAILED EXCHANGE OCCURRED ON THE (B)(6) OF (B)(6) 2019 AND THE EXPLANT THEN OCCURRED ON THE (B)(6) OF (B)(6) 2020. THIS INCREASE IN INDWELL TIME COULD HAVE RESULTED IN EITHER STENT ENCRUSTATION OR TISSUE INGROWTH, INHIBITING ITS REMOVAL AS A RESULT OF THIS EXTENDED DWELL TIME. PLEASE NOTE AS PER ADDITIONAL INFORMATION RECEIVED ON 14TH OF MAY AFTER THE INVESTIGATION WAS COMPLETED IT WAS CONFIRMED THAT THE STENTS HAD EVIDENCE OF ENCRUSTATION AND THE PATIENT WAS TREATED WITH BILATERAL NEPHROSTOMY TUBES FROM (B)(6) 2019 UNTIL THE (B)(6) 2020 AND THE PATIENT CONDITION WAS STABLE DURING THIS TIME. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A SECOND PROCEDURE WAS REQUIRED TO REMOVE THE STENTS AND THERE WAS INCREASED STONE FORMATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PER REP - (B)(6) 2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6) MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. PER REP - (B)(6) 2020 - THE PROCEDURE WAS HELD AT (B)(6) MEDICAL CENTER HILLCREST (C12016-3). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). PER COMPLAINT FORM - (B)(6) 2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL. THE REP HAS BEEN ASKED TO PROVIDE INTERVENTION AND PATIENT OUTCOME INFORMATION. -MS (B)(6) 2020 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -YES IF YES, PLEASE DESCRIBE. -FAILED EXCHANGE ON (B)(6) 2020 / EXPLANTED ON 04FEB2020 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -YES IF YES, PLEASE DESCRIBE. -BILATERAL PERCUTANEOUS RENAL DILATION W/ STENT REMOVAL (B)(6) 2020. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -YES IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. -BILATERAL PERCUTANEOUS RENAL DILATION W/ STENT REMOVAL (B)(6) 2020. 4. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -YES. 5. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -YES. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. -STONE FORMATION.
PER REP - (B)(6) 2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6) MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. PER REP - (B)(6) 2020 - THE PROCEDURE WAS HELD AT (B)(6) MEDICAL CENTER (C12016-3). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). - PER COMPLAINT FORM - (B)(6) 2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL. THE REP HAS BEEN ASKED TO PROVIDE INTERVENTION AND PATIENT OUTCOME INFORMATION. -MS (B)(6) 2020. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -YES. IF YES, PLEASE DESCRIBE. FAILED EXCHANGE ON (B)(6) 2020 / EXPLANTED ON (B)(6) 2020. 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -YES IF YES, PLEASE DESCRIBE. -BILATERAL PERCUTANEOUS RENAL DILATION W/ STENT REMOVAL (B)(6) 2020. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -YES IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. -BILATERAL PERCUTANEOUS RENAL DILATION W/ STENT REMOVAL (B)(6) 2020. 4. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? YES. 5. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. STONE FORMATION.
- PER REP - 04EB2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6), MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. - PER REP - 05FEB2020 - THE PROCEDURE WAS HELD AT (B)(6) MEDICAL CENTER (B)(6) (C12016-3). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). - PER COMPLAINT FORM - 13FEB2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL. PER ADDITIONAL INFORMATION RECEIVED ON 14TH OF MAY THE STENTS HAD EVIDENCE OF ENCRUSTATION AND THE PATIENT WAS TREATED WITH BILATERAL NEPHROSTOMY TUBES FROM (B)(6) 2019 UNTIL THE (B)(6) 2020 AND THE PATIENT CONDITION WAS STABLE DURING THIS TIME.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PER REP - 04EB2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6), MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. PER REP - 05FEB2020 - THE PROCEDURE WAS HELD AT (B)(6). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (B)(4) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). PER COMPLAINT FORM - 13FEB2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245760 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | G34111 | C1477851 | 10827002341118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |