MEMORY HARD WIRE BASKET
Report
- Report Number
- 1037905-2020-00194
- Event Type
- Injury
- Date Received
- May 6, 2020
- Date of Event
- November 18, 2016
- Report Date
- April 7, 2020
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- FFL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
CONTINUE FROM CONCOMITANT PRODUCTS: ZEBRA WIRE GUIDE, MTW-0.027. COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME, TRI-25M. COOK TRI-EX TRIPLE LUMEN EXTRACTION BALLOON, TX-15-A. YIN, P., WANG, M., QIN, R. ET AL. INTRAOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE OVER PRIMARY CLOSURE OF THE COMMON BILE DUCT FOR CHOLEDOCHOLITHIASIS COMBINED WITH CHOLECYSTOLITHIASIS: A COHORT STUDY OF 211 CASES. SURG ENDOSC 31, 3219¿3226 (2017). HTTPS://DOI.ORG/10.1007/S00464-016-5348-1. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. EVALUATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A DEVICE FAILURE WAS NOT IDENTIFIED IN THE ARTICLE, ONLY POST PROCEDURE COMPLICATIONS. THE INSTRUCTIONS FOR USE INCLUDES POTENTIAL COMPLICATIONS: ¿THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY AND ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, SEPSIS, PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, HYPOTENSION, ALLERGIC REACTION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. OTHERS ASSOCIATED WITH BASKET EXTRACTION INCLUDE, BUT ARE NOT LIMITED TO: IMPACTION OF OBJECT, ASPIRATION OF FOREIGN BODY, LOCALIZED INFLAMMATION, PRESSURE NECROSIS." PRIOR TO DISTRIBUTION, ALL MEMORY HARD WIRE BASKETS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
CONTINUE FROM CONCOMITANT PRODUCTS: ZEBRA WIRE GUIDE, MTW-0.027. COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME, TRI-25M. COOK TRI-EX TRIPLE LUMEN EXTRACTION BALLOON, TX-15-A. YIN, P., WANG, M., QIN, R. ET AL. INTRAOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE OVER PRIMARY CLOSURE OF THE COMMON BILE DUCT FOR CHOLEDOCHOLITHIASIS COMBINED WITH CHOLECYSTOLITHIASIS: A COHORT STUDY OF 211 CASES. SURG ENDOSC 31, 3219¿3226 (2017). HTTPS://DOI.ORG/10.1007/S00464-016-5348-1. INVESTIGATION EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A DEVICE FAILURE WAS NOT IDENTIFIED IN THE ARTICLE, ONLY POST PROCEDURE COMPLICATIONS. THE INSTRUCTIONS FOR USE INCLUDES POTENTIAL COMPLICATIONS: ¿THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY AND ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, SEPSIS, PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, HYPOTENSION, ALLERGIC REACTION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. OTHERS ASSOCIATED WITH BASKET EXTRACTION INCLUDE, BUT ARE NOT LIMITED TO: IMPACTION OF OBJECT, ASPIRATION OF FOREIGN BODY, LOCALIZED INFLAMMATION, PRESSURE NECROSIS." PRIOR TO DISTRIBUTION, ALL MEMORY HARD WIRE BASKETS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING TWO (2) COOK MEMORY HARD WIRE BASKET (MWB-3X6). PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. ¿¿THE SURGEON STOOD IN FRONT OF THE PATIENT¿S FACE AND INSERTED THE DUODENAL ENDOSCOPE (OLYMPUS CV-260) GENTLY INTO THE PATIENT¿S DESCENDANT DUODENUM TO FIND THE BILE PAPILLA. THE BEST ANGLE IS OBTAINED BY ADJUSTING THE DUODENAL ENDOSCOPE TO ENABLE SMOOTH INSERTION OF THE PAPILLOTOME (WILSON-COOK TRI-25 M) INTO THE BILE PAPILLA. THE CONTRAST MEDIUM SHOULD BE INJECTED SLOWLY SO THAT THE ENDOSCOPIST CAN ACQUIRE A CLEAR VIEW OF THE NUMBER AND SIZE OF STONES IN THE COMMON BILE DUCT (CBD) UNDER X-RAY. A ZEBRA GUIDE WIRE (MTW-0.027) WAS INSERTED INTO THE CBD THROUGH THE PAPILLOTOME TO ENABLE THE BILE PAPILLA TO BE CUT OPEN. FOLLOWING THIS PREPARATION WORK, A BASKET (WILSON-COOK MWB-3X6) OR BALLOON (WILSON-COOK TX-15-A) WAS INSERTED INTO THE CBD TO EXTRACT STONES. THIS PROCEDURE WAS REPEATED SEVERAL TIMES UNTIL STONES WERE NO LONGER OBSERVED IN THE CBD UNDER X-RAY... TWO (1.87%) PATIENTS IN GROUP B DEVELOPED POST-ERCP PANCREATITIS, WHICH WAS RESOLVED WITH ADMINISTRATION OF OCTREOTIDE AT 25 LG/H FOR 1¿2 WEEKS...¿ IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. POST-ERCP PANCREATITIS WAS TREATED WITH OCTREOTIDE (SOMATOSTATIN ANALOG; USED AS A PHARMACOLOGICAL INHIBITOR OF EXOCRINE PANCREATIC SECRETION FOR TREATMENT OF PANCREATITIS) FOR ONE TO TWO WEEKS AND RESOLVED. THE CLINICAL LITERATURE ARTICLE STATES THAT THREE COOK DEVICES WERE USED; THE COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME (TRI-25 M), COOK MEMORY HARD WIRE BASKET (MWB-3X6) AND COOK TRI-EX EXTRACTION BALLOON (TX-15-A). THIS FOLLOW-UP MDR IS BEING SENT TO CAPTURE THIS OCCURRENCE WHERE THE COOK MEMORY HARD WIRE BASKET (MWB-3X6) DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE POST-ERCP PANCREATITIS. A FOLLOW-UP MDR FOR THE TWO OTHER COOK DEVICES WILL BE SUBMITTED SEPARATELY.
CONCOMITANT MEDICAL PRODUCTS: MTW-0.027 GUIDE WIRE, COOK TRI-25M SPHINCTEROTOME, COOK TX-15-A EXTRACTION BALLOON. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. YIN, P., WANG, M., QIN, R. ET AL. INTRAOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE OVER PRIMARY CLOSURE OF THE COMMON BILE DUCT FOR CHOLEDOCHOLITHIASIS COMBINED WITH CHOLECYSTOLITHIASIS: A COHORT STUDY OF 211 CASES. SURG ENDOSC 31, 3219¿3226 (2017). HTTPS://DOI.ORG/10.1007/S00464-016-5348-1.
COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2017. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. ¿¿THE SURGEON STOOD IN FRONT OF THE PATIENT¿S FACE AND INSERTED THE DUODENAL ENDOSCOPE (OLYMPUS CV-260) GENTLY INTO THE PATIENT¿S DESCENDANT DUODENUM TO FIND THE BILE PAPILLA. THE BEST ANGLE IS OBTAINED BY ADJUSTING THE DUODENAL ENDOSCOPE TO ENABLE SMOOTH INSERTION OF THE PAPILLOTOME (WILSON-COOK TRI-25 M) INTO THE BILE PAPILLA. THE CONTRAST MEDIUM SHOULD BE INJECTED SLOWLY SO THAT THE ENDOSCOPIST CAN ACQUIRE A CLEAR VIEW OF THE NUMBER AND SIZE OF STONES IN THE COMMON BILE DUCT (CBD) UNDER X-RAY. A ZEBRA GUIDE WIRE (MTW-0.027) WAS INSERTED INTO THE CBD THROUGH THE PAPILLOTOME TO ENABLE THE BILE PAPILLA TO BE CUT OPEN. FOLLOWING THIS PREPARATION WORK, A BASKET (WILSON-COOK MWB-3X6) OR BALLOON (WILSON-COOK TX-15-A) WAS INSERTED INTO THE CBD TO EXTRACT STONES. THIS PROCEDURE WAS REPEATED SEVERAL TIMES UNTIL STONES WERE NO LONGER OBSERVED IN THE CBD UNDER X-RAY... TWO (1.87%) PATIENTS IN GROUP B DEVELOPED POST-ERCP PANCREATITIS, WHICH WAS RESOLVED WITH ADMINISTRATION OF OCTREOTIDE AT 25 LG/H FOR 1¿2 WEEKS...¿ IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. POST-ERCP PANCREATITIS WAS TREATED WITH OCTREOTIDE (SOMATOSTATIN ANALOG; USED AS A PHARMACOLOGICAL INHIBITOR OF EXOCRINE PANCREATIC SECRETION FOR TREATMENT OF PANCREATITIS) FOR ONE TO TWO WEEKS AND RESOLVED. THE CLINICAL LITERATURE ARTICLE STATES THAT THREE COOK DEVICES WERE USED; THE COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME (TRI-25 M), COOK MEMORY HARD WIRE BASKET (MWB-3X6) AND COOK TRI-EX EXTRACTION BALLOON (TX-15-A). THIS MDR IS BEING SENT TO CAPTURE THIS OCCURRENCE WHERE THE COOK MEMORY HARD WIRE BASKET (MWB-3X6) DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE POST-ERCP PANCREATITIS. AN MDR FOR THE TWO OTHER COOK DEVICES WILL BE SUBMITTED SEPARATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 494142 | MEMORY HARD WIRE BASKET | FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL | FFL | COOK ENDOSCOPY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | OLYMPUS CV-260 ENDOSCOPE| OLYMPUS CV-260 VIDEO SYSTEM AND DUODENOSCOPE |