MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-21-480

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Edema (1820); No Consequences Or Impact To Patient (2199)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: terumo.20 wire guide.Investigation evaluation: the three (3) devices said to be involved were returned in opened pouches from the lot number provided in the report.The labels match the products returned.Device one (1) - our laboratory evaluation of the product said to be involved confirmed the report.The sphincterotome was returned with the associated wire guide lodged in the sphincterotome.During a visual examination, it was observed that the cannulated metal hub and black wire guide shrink tube had separated from each other, resulting in the shrink tube moving freely on the catheter and the metal hub moving freely on the wire guide.The wire guide had stripped the catheter by approximately 4 cm through the black shrink tube on the proximal end below the handle.The black shrink tube was removed and the catheter was stripped to recover the wire guide.There were two (2) areas observed on the catheter approximately 5.5 cm and 10 cm from the proximal end where the catheter material had expanded, due to wire guide coating damage inside the catheter.Kinks were observed in the catheter approximately 27.5 cm, 51.5 cm and 69.5 cm from the proximal end of the catheter.The wire guide was recovered from the catheter and a visual examination was performed.Wire guide coating had bunched up between 64 cm and 81.5 cm from the distal end of the wire guide.The two (2) areas where wire guide coating had bunched up causing areas of the catheter material to expand were approximately 66.5 cm and 72.5 cm from the distal end.Bare core wire was observed between 81.5 cm - 88.8 cm from the distal end of the wire guide.Wire guide coating had again bunched up between 88.8 cm and 111.2 cm from the distal end of the wire guide.Bare core wire was observed between 111.2 cm - 192 cm from the distal end of the wire guide.A small amount of fraying was observed at 192 cm and wire guide coating had bunched up between 192 cm and 195.5 cm.A functional test could not be performed due to the condition of the returned device.Device two (2) - our laboratory evaluation of the product said to be involved could not confirm the report.The sphincterotome was returned with the associated wire guide.During a visual examination, it was observed that the catheter had a kink approximately 68.5 cm from the proximal end.During a functional test, the sphincterotome loaded with the wire guide was advanced through a duodenoscope that is placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160v).The tip of the device entered the papilla and the sphincterotome was then removed using a long wire exchange with the wire guide remaining in the papilla without any difficulty.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.Device three (3) - our laboratory evaluation of the product said to be involved could not confirm the report.The sphincterotome was returned with the associated wire guide.During a visual examination, it was observed that the catheter had kinks approximately 24 cm and 34 cm from the proximal end.During a functional test, the sphincterotome loaded with the wire guide was advanced through a duodenoscope that is placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160v).The tip of the device entered the papilla and the sphincterotome was then removed using a long wire exchange with the wire guide remaining in the papilla without any difficulty.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The device history record for the lot number said to be involved contained nonconformances of kinking and twisting that could all potentially be related to the reported observation.The subassembly device history record for the wire guide contains a nonconformance for moving shrink tubing that could also potentially relate to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used three (3) cook fusion omni-tome pre-loaded sphincterotomes.Upon cannulating [attempting to], they used the device to cannulate with the wire guide that was provided but could not cannulate, so they removed that wire guide and put in another manufacturer's wire guide.They were able to cannulate, but other manufacturer's wire guide was too floppy, so it was taken out [of the sphincterotome] and the cook wire guide that comes with it [the pre-loaded wire guide] was reused.They got "where they needed to go," but when the doctor went to remove [the sphincterotome], the sphincterotome caught the wire guide and the wire guide would not come back or go forward [difficult exchange].It was stuck in place.At that point, they attempted to wiggle [the device], and there was no progress.The wire guide kept shredding (outer coat) as force applied forward or backwards [coating damage].The entire device had to be pulled out, and it lost the physician's cannulation [lost wire guide access, subject of this report].This was the first device.They attempted to use another omni-tome.It was a similar situation, but they did not wait for it [the wire guide] to shred before removing the product (second device) [also subject of this report].A third attempt resulted in same result as second device, but at that point there was too much edema [swelling], so the procedure was aborted after around 2.5 hours (third device) [also subject of this report].The following was received on 08/07/2018: per the customer, "this isn¿t the first time that we have this issue with this tome.It happens quite frequently we just don¿t report it to your company every time that it does." see related mdr 1037905-2018-00369.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient experienced edema due to this occurrence.

Event Description

The following was initially reported on 20-august-2018: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used three (3) cook fusion omni-tome pre-loaded sphincterotomes.Upon cannulating [attempting to], they used the device to cannulate with the wire guide that was provided but could not cannulate, so they removed that wire guide and put in another manufacturer's wire guide.They were able to cannulate, but other manufacturer's wire guide was too floppy, so it was taken out [of the sphincterotome] and the cook wire guide that comes with it [the pre-loaded wire guide] was reused.They got "where they needed to go," but when the doctor went to remove [the sphincterotome], the sphincterotome caught the wire guide and the wire guide would not come back or go forward [difficult exchange].It was stuck in place.At that point, they attempted to wiggle [the device], and there was no progress.The wire guide kept shredding (outer coat) as force applied forward or backwards [coating damage].The entire device had to be pulled out, and it lost the physician's cannulation [lost wire guide access, subject of this report].This was the first device.They attempted to use another omni-tome.It was a similar situation, but they did not wait for it [the wire guide] to shred before removing the product (second device) [also subject of this report].A third attempt resulted in same result as second device, but at that point there was too much edema [swelling], so the procedure was aborted after around 2.5 hours (third device) [also subject of this report].The following was received on 08/07/2018: per the customer, "this isn¿t the first time that we have this issue with this tome.It happens quite frequently we just don¿t report it to your company every time that it does." see related mdr 1037905-2018-00369." the following was received on 30-august-2018: "due to the fact that the cannulation was difficult and that we had to pull the entire sphincterotome out of the ampulla and we could not regain access to the common bile duct, the patient had to go to ir [interventional radiology] for a transhepatic cholangiogram." a section of the device did not remain inside the patient¿s body.The patient required a transhepatic cholangiogram; however, this is not considered intervention to preclude a serious injury or death, but a continuation of treatment.According to the initial reporter, the patient experienced edema due to this occurrence.

• Brand Name: FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7799087
• MDR Text Key: 117867862
• Report Number: 1037905-2018-00366
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002486768
• UDI-Public: (01)00827002486768(17)201101(10)W3989617
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: FS-OMNI-21-480
• Device Lot Number: W3989617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJFQ 180V ENDOSCOPE