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COOK ENDOSCOPY D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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| Catalog Number DASH-21-480 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Inflammation (1932)
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| Event Date 07/25/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Emilio jesús de la morena madrigal, garcía, m.I.R., ródenas, a.B.G., & arellano, e.P.(2017).Biliary cannulation effectiveness and pancreatitis risk using two early precut techniques.Revista española de enfermedades digestivas.Doi: 10.17235/reed.2017.5175/2017.Date range of the information contained in the article: 2013 to 2016.Concomitant medical products: olympus tjf-160vr endoscope, fujinon ed-250xt5, boston scientific autotome rx-44 cannulotomes, jagwire/hydra-jagwire 0.035¿ guidewires.Cook tracer-metro 0.021¿ guidewires, olympus clever-cut-3v cannulotomes with visiglide 0.025¿ guidewires, erbe vio-200s, olympus hf-120 and erbe icc-200 diathermy generators.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided with 30 days of submission of this report.
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Event Description
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During five (5) endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used five (5) cook d.A.S.H.Dometip double lumen sphincterotomes.".For a minority of cases, cook medical (bloomington in, usa) dash-21-480 cannulotomes with tracer-metro 0.021¿ guidewires.Were used.[transpancreatic precuts] tpp were performed using the same cannulotome as the simple cannulation procedure.Tpp was also a two-step procedure.The first step involved a pancreatic sphincterotomy about 5-10 mm in length, extending towards the ¿1 o'clock¿ position in order to incise the whole of the pancreatic sphincter, which exposes the septum including the intraduodenal bile duct.The second step involves a 3-5 mm incision of the bile duct, extending towards the ¿11 o'clock¿ position.The position of the cannulotome in the pancreatic duct was confirmed by the guidewire inside and pancreatography was restricted to those cases where the guidewire could not be advanced to the pancreatic body, thus casting doubt on its location.The guidewire was maintained within the pancreatic duct during the tpp.Biliary cannulation (bc) was again attempted with a conventional cannulotome and a hydrophilic guidewire after the precut.Following bc, the precut was extended, always using a standard traction-type sphincterotome (sts) of an appropriate size for the papillary anatomy and therapeutic indication.Five [pancreatitis cases] were reported among the 79 tpp cases (subject of this report).The two severe pancreatitis events in the tpp group were more clinically serious conditions (4-month hospitalization and one surgical procedure) as compared to the two events reported for the simple cannulation group (24 and 35 days in hospital)." it was not published in the article if a section of the device remained inside the patient¿s body.Three (3) patients required hospitalization, one (1) patient required a surgical procedure, one (1) patient is unknown due to pancreatitis.The patients experienced pancreatitis due to this occurrence in the published article.
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Manufacturer Narrative
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Emilio jesús de la morena madrigal, garcía, m.I.R., ródenas, a.B.G., & arellano, e.P.(2017).Biliary cannulation effectiveness and pancreatitis risk using two early precut techniques.Revista española de enfermedades digestivas.Doi: 10.17235/reed.2017.5175/2017 date range of the information contained in the article: 2013 to 2016.Continued from d11: olympus tjf-160vr endoscope, fujinon ed-250xt5, boston scientific autotome rx-44 cannulotomes, jagwire/hydra-jagwire 0.035¿ guidewires.Cook tracer-metro 0.021¿ guidewires, olympus clever-cut-3v cannulotomes with visiglide 0.025¿ guidewires, erbe vio-200s, olympus hf-120 and erbe icc-200 diathermy generators 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.The device history record for the lot number said to be involved could not be reviewed because a lot number was not provided.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 (ifu) includes the following regarding 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.Prior to distribution, all d.A.S.H.Dometip double lumen sphincterotomes are subjected to a visual inspection 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.
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Event Description
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During five (5) endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used five (5) cook d.A.S.H.Dometip double lumen sphincterotomes.".For a minority of cases, cook medical (bloomington in, usa) dash-21-480 cannulotomes with tracer-metro 0.021¿ guidewires.Were used.[transpancreatic precuts] tpp were performed using the same cannulotome as the simple cannulation procedure.Tpp was also a two-step procedure.The first step involved a pancreatic sphincterotomy about 5-10 mm in length, extending towards the ¿1 o¿clock¿ position in order to incise the whole of the pancreatic sphincter, which exposes the septum including the intraduodenal bile duct.The second step involves a 3-5 mm incision of the bile duct, extending towards the ¿11 o¿clock¿ position.The position of the cannulotome in the pancreatic duct was confirmed by the guidewire inside and pancreatography was restricted to those cases where the guidewire could not be advanced to the pancreatic body, thus casting doubt on its location.The guidewire was maintained within the pancreatic duct during the tpp.Biliary cannulation (bc) was again attempted with a conventional cannulotome and a hydrophilic guidewire after the precut.Following bc, the precut was extended, always using a standard traction-type sphincterotome (sts) of an appropriate size for the papillary anatomy and therapeutic indication.Five [pancreatitis cases] were reported among the 79 tpp cases (subject of this report).The two severe pancreatitis events in the tpp group were more clinically serious conditions (4-month hospitalization and one surgical procedure) as compared to the two events reported for the simple cannulation group (24 and 35 days in hospital)." it was not published in the article if a section of the device remained inside the patient¿s body.Three (3) patients required hospitalization, one (1) patient required a surgical procedure, one (1) patient is unknown due to pancreatitis.The patients experienced pancreatitis due to this occurrence in the published article.
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