MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-XL-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medwork papillotome, pap1, boston scientific dreamwire 0.035inx450cm, (b)(4), pancreatic stent (5 f, 5cm), unknown make or model.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.There were five (5) photos provided by the user.Three (3) of the photos are fluoroscopy images.It appears that these three (3) photos were taken during the first sweep of the common bile duct.The additional two (2) photos provided show images of the papilla before and after the sweep of the bile duct.We can confirm that the papillary roof was bleeding.It is unknown when the bleeding occurred.Without substantial evidence to contradict the complaint, it is considered confirmed based solely on statements describing the event.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use includes potential complications: ¿potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complications that can occur during endoscopic balloon extraction include, but are not limited to: stone impaction, localized inflammation, pressure necrosis.¿ the instructions for use includes the following to ensure proper use of the device: "after verifying desired position of balloon, inflate balloon with air only.Note for multiple sizing balloons: inflate balloon using fluoroscopic monitoring until balloon is visualized occluding duct.If desired, adjust size of balloon by using reference marks on syringe.To achieve smallest balloon size, inflate balloon to next largest size and gently pull back on syringe to initial size.Lock stopcock.Using fluoroscopic visualization and keeping endoscope elevator open, gently withdraw the inflated balloon toward the papilla.Warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy." prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.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 and this represents an isolated 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon (fs-qeb-xl-a).Per the initial reporter: ¿dr.(b)(6) used [for the] first time a fs-qeb-xl-a extraction balloon; before, he had always used another manufacturer's extraction balloons.First, a sphincterotomy was performed and another manufacturer's wire guide was introduced in bile duct over which the fs-qeb-xl-a was advanced into the duct.According to the nurse, the balloon was inflated up to 15 mm.When the balloon was retracted, it suddenly burst.The physician states that this caused a perforation of the papillary roof (with visibility of the intramural part of the bile duct).A clip was placed to close the perforation, and a cook 10 french, 7 cm cotton leung stent was placed into the bile duct.A little oozing bleeding was visible, but without need of further intervention.Later, the bleeding got more intensive, so the patient received two blood transfusions, plus antibiotics and was admitted to the intensive care unit.The balloon was discharged [discarded] during the stressful situation and is not available for further examinations [investigation].¿ the following information was received on 11/22/2017, eliminating the malfunction previously reported: the patient's tissue did not have any inflammatory changes.The length of the sphincterotomy incision was 5 mm at 12 o'clock.There was one (1), five (5) mm stone to be extracted.The stone was extracted in first sweep.There was no force or tension necessary to remove the stone.The balloon was inserted again for a second sweep to assure no stones were left in the duct.During this sweep, the balloon got in pre-papillary position (smaller in diameter), so it was inflated again with 2.5 ml of air.During the expansion of the balloon, the papillary roof perforated and an oozing bleeding occurred.After bleeding occurred, a biliary stent (cook cotton leung 10 f, 7cm) was placed to keep the papilla and access to the duct open, but there was no clip placed (incorrect information from the initial reporter).The patient received antibiotics as well as blood transfusion (2 units).On day three [of the patient's hospital stay], a control gastroscopy was performed.There was no active bleeding.The pancreatic stent (5 f, 5 cm), that was placed to get better access to the bile duct before sphincterotomy, was removed.The bile duct stent was left in position.The patient recovered and was discharged one week after the intervention.Further information was received on 11/27/2017: at first, the information received by the cook sales representative from the customer stated that the perforation occurred when the balloon ruptured.When the cook sales representative visited the physician on (b)(6) 2017, it was confirmed by the physician that the perforation occurred while inflating the balloon.A translation of the patient's chart notes regarding this incident was received on 11/27/2017: "ercp: ¿splinting¿ of the d.W.[pancreatic duct] by a pigtail 5 cm/5 f, selective cannulation of the dhc with a wire guided sphincterotome; est (endoscopic sphincterotomy) of about 5 mm, balloon sweep without problems.For definite exclusion of residual concrements another balloon sweep; prepapillary reduction of balloon diameter with collapse of balloon, therefore repeated inflation of balloon with 2.5 ml air, therefore ¿overreacting¿ expansion of balloon with tear of papillary roof and oozing bleeding.To assure of bile drainage, in case of blood clot, introduction of a 7 cm/10 f bile duct prosthesis.Progression: antibiotic covering (piperacillin/ tazobactam/ metronidazol) i.V.[intravenously], abstinence from food, central venous catheter placement, parenteral nutrition, analgesia, infusion treatment, transfusion of 2 erythrocyte concentrates due to decrease of hb (hemoglobin) < 7 g/dl; ct abdomen for clarification of retroperitoneal fistula.Control gastroscopy on 3rd day; hemostasis, pancreatic stent is extracted, biliary drainage left in place.Stabilization in further progression, food building, discharge 1 week after intervention.Revisit for elective cholecystectomy after 4 weeks.".

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7097249
• MDR Text Key: 94158658
• Report Number: 1037905-2017-00745
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002319219
• UDI-Public: (01)00827002319219(17)180814(10)W3902469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-XL-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2017
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/07/2017
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENTAX 120D052 DUODENOSCOPE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53