MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-EX EXTRACTION BALLOON

Catalog Number TX-15-A

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

Patient Problem Inflammation (1932)

Event Date 11/18/2016

Event Type  Injury  

Manufacturer Narrative

Gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.Concomitant medical products: mtw-0.027 guide wire.Cook tri-25m sphincterotome.Cook mwb-x6 extraction basket.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.[(b)(4)].

Event Description

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 cook tri-ex extraction balloon (tx-15-a) device may have caused or contributed to the post-ercp pancreatitis.An mdr for the two other cook devices will be submitted separately.

Event Description

Cook endoscopy was notified of this event involving two (2) cook tri-ex extraction balloon (tx-15-a).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 cook tri-ex extraction balloon (tx-15-a) 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.

Manufacturer Narrative

Continue from concomitant products: zebra wire guide, mtw-0.027.Cook memory basket 7 fr hard wire, mwb-3x6.Cook tri-tome pc triple lumen sphincterotome, tri-25m.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 product said to be involved was 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 product said to be involved was 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 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.Those that can occur during endoscopic balloon extraction include, but are not limited to: stone impaction, localized inflammation, pressure necrosis.¿ prior to distribution, all tri-ex 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.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.

• Brand Name: TRI-EX EXTRACTION BALLOON
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10030517
• MDR Text Key: 196921176
• Report Number: 1037905-2020-00193
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TX-15-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS CV-260 ENDOSCOPE; OLYMPUS CV-260 VIDEO SYSTEM AND DUODENOSCOPE
• Patient Outcome(s): Required Intervention