MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION TRIPLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-25M-35

Device Problem Failure to Align (2522)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: the product was returned for evaluation and the investigation is on-going.A follow-up medwatch report will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion triple lumen sphincterotome.There were orientation problems.The following additional information was received on 12/07/17: the tip is not going in the direction as it is supposed to.The cutting direction was 5/6 o'clock [incorrect cutting wire orientation] the second problem was that cutting wire could not be tensed [unable to bow], when the hydrophilic wire part was not in the area of the cutting wire (the wire is more rigid in the proximal area).The patient experienced arterial bleeding in the area of the papilla and intervention was required.The physician suspected that the bleeding was caused by the incorrect cutting wire direction.Clarification was received on 12/21/17 that surgical treatment was required.

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: an evaluation of the returned device confirmed the report on incorrect cutting wire orientation.During our laboratory analysis, the handle was retracted and the sphincterotome was bowed.The sphincterotome bowed without any difficulty.It was then advanced through a duodenoscope that is placed in a simulated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 catheter exited the endoscope with the cutting wire facing 2 o¿clock.The device was then bowed and the cutting wire was facing 3 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was not observed at the distal end.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The associated wire guide and wire guide pin vise were included in the return.A visual examination of the wire guide showed kinks at approximately 4 cm and 30 cm from the distal end.The device history record for the lot number said to be involved was reviewed.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.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user: "upon removing device from packaging, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip." the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all fusion triple lumen sphincterotomes are subjected to a visual inspection and functional test 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: 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.Concomitant medical products erbe electrosurgical generator investigation evaluation: an evaluation of the returned device confirmed the report on incorrect cutting wire orientation.During our laboratory analysis, the handle was retracted and the sphincterotome was bowed.The sphincterotome bowed without any difficulty.It was then 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 catheter exited the endoscope with the cutting wire facing 2 o¿clock.The device was then bowed and the cutting wire was facing 3 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was not observed at the distal end.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The associated wire guide and wire guide pin vise were included in the return.A visual examination of the wire guide showed kinks at approximately 4 cm and 30 cm from the distal end.The device history record for the lot number said to be involved was reviewed.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.Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user: "upon removing device from packaging, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip." the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all fusion triple lumen sphincterotomes are subjected to a visual inspection and functional test 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: 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

The following was reported to the fda on (b)(6) 2017: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion triple lumen sphincterotome.There were orientation problems.The following additional information was received on (b)(6) 2017: the tip is not going in the direction as it is supposed to.The cutting direction was 5/6 o'clock [incorrect cutting wire orientation] the second problem was that cutting wire could not be tensed [unable to bow], when the hydrophilic wire part was not in the area of the cutting wire (the wire is more rigid in the proximal area).The patient experienced arterial bleeding in the area of the papilla and intervention was required.The physician suspected that the bleeding was caused by the incorrect cutting wire direction.Clarification was received on 12/21/ 2017 that surgical treatment was required." the following additional information was received on 12/28/2017: the patient required surgery (serging [sewing] the gastroduodenal artery), and received t-drainage.After the surgical care, the patient was yellow [jaundiced].The cause was a coagulum [blood clot].After removing the coagulum, the patient bled again.The patient received three (3) plastic stents, which will be removed soon.

• Brand Name: FUSION TRIPLE LUMEN 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: 7139601
• MDR Text Key: 95591294
• Report Number: 1037905-2017-00777
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002315334
• UDI-Public: (01)00827002315334(17)200919(10)W3908195
• Combination Product (y/n): N
• PMA/PMN Number: K033203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-25M-35
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS DUODENOSCOPE, UNKNOWN MODEL
• Patient Outcome(s): Required Intervention