MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number UNKNOWN

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

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: name: howell d.A.S.H.Sphincterotome.Patient information: age: average age for tps was 60.2 years old.Gender: 53.7% female.Pma/520(k #): k172665.Citation: rejeski, j., hines, m., jones, j., conway, j., mishra, g., evans, j., & pawa, r.(2020).Outcomes of precut sphincterotomy techniques in cases of difficult biliary access.Frontline gastroenterology, 12(2), 113117.Https://doi.Org/10.1136/flgastro-2019-101380.The investigation is on-going.A follow-up emdr will be provided following the completion of the investigation.

Event Description

Cook endoscopy was notified of this event via a clinical literature article.The article was published in 2020 and it was reported that two (2) patients experienced bleeding in procedures where cook howell d.A.S.H.Sphincterotomes were used.Included are relevant excerpts from the article: this study aims to define success and complication rates of.Tps [transpancreatic papillary septotomy] techniques for difficult biliary access cases as experienced at a single, high-volume endoscopy centre.We performed our study at a large, tertiary-care medical centre where all ercps [endoscopic retrograde cholangiopancreatography] were performed by, or under the direct supervision of, two experienced advanced endoscopist.We retrospectively interrogated our endoscopy report database to identify all ercps performed at our medical centre between (b)(6) 2014 and (b)(6) 2017.We identified all patients who underwent ercp during this time and subsequently performed a chart review to identify procedural details and review at least 4 months of post-procedure follow-up data.All tps were performed with either a fusion omni-tome or a howell d.A.S.H.Sphincterotome [subject of report].Tps was performed if the pancreatic duct was preferentially cannulated more than twice, at which point, erbe electrocautery was applied with use of the bow knife function in the direction of the bile duct in an effort to incise the septum and afford for subsequent cannulation of the bile duct.Bleeding occurred in 2 (2.3%) patients in the tps group [subject of report].It was not reported if a section of the device remained inside the patients body.It was not reported if the patient required any additional procedures due to this occurrence, however intervention may have been completed.According to the initial reporter, the patients experienced bleeding following ercp.

Manufacturer Narrative

D.Suspect medical device: name: (b)(6).A.Patient information age: average age for tps was 60.2 years old.Gender: 53.7% female.Pma/520(k #): k172665.Citation: (b)(6).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.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.However a device failure was not reported in the article.The article reported occurrences of bleeding.Bleeding is a known complication of these types of procedures.The instructions for use include the following 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 and functional test to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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: D.A.S.H. DOMETIP DOUBLE 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: 12189339
• MDR Text Key: 262256568
• Report Number: 1037905-2021-00321
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERBE VIO 300D; PENTAX, ED-3490TKOR ED-3270K; ERBE VIO 300D; PENTAX, ED-3490TKOR ED-3270K
• Patient Outcome(s): Required Intervention