MAUDE Adverse Event Report: COSMO TECHNOLOGIES, LTD. ELEVIEW; SUBMUCOSAL INJECTION AGENT

Lot Number UH143

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bowel Perforation (2668)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

Information missing from importer report: see below.Patient event code labeling statement: with regard to bowel perforation, the uses section of the device labeling for eleview states the following: "eleview, as a colored clear emulsion, helps to clarify the area where it is injected, to assist the endoscopist in visualizing the margins of the target lesion and performing the resection procedure, thereby decreasing the risk of damaging the external muscular layer, which could lead to perforation." however, there is no reference to "bowel perforation" in the warnings and precautions section.Discussion of missing information: the following required information is missing: requested from reporter, but unavailable: model number, catalog number, serial number, and unique device identifier (udi).Dates of device implantation and explantation, name and address of reprocessor, follow-up report type, and type of remedial action initiated and correction/removal reporting number.

Event Description

Colonoscopy with post procedure para-abdominal pain; a proximal transverse colon perforation was confirmed [procedural intestinal perforation].Case description: on (b)(6) 2018, a spontaneous report was received from a physician via a company representative regarding a (b)(6)-year-old caucasian male who was being treated with eleview (submucosal injection agent).On (b)(6) 2018, additional information was received from a physician and the case was assessed as serious and unexpected.Medical history included that the patient was described as "healthy", had colon polyps, a "recent bout" (relative to (b)(6) 2018) of diarrhea and bloody stool which was likely infectious colitis (all had resolved at the time of the procedure); and a ct (computerized tomogram) scan which showed colonic thickening.Concomitant products included: citalopram 20 mg 1x/day, doxazosin 2 mg at bedtime, loratadine 10 mg 1x/day, losartan 50 mg 1x/day, pravastatin 40 mg 1x/day, ranitidine 150 mg 2x/day and dietary supplements of: saw palmetto 160 mg 2x/day and a multivitamin.On (b)(6) 2018, the patient had treatment with eleview at 5 ml for 2 polyps, during a colonoscopy procedure for polypectomies.On (b)(6) 2018, after the eleview was injected under the base of a 1.5 cm "quite flat" polyp in the proximal transverse colon, the polyp "sort of became a mushroom-shaped lesion." the polyp lifted off the mucosa, but created a "neck," where the snare tended to settle.This "neck" must have made the "conventional hot" snare be too close to the serosa and caused the snare to cut too deep.After excising the lesion (later identified as sessile serrated adenoma), the patient was sent home.After a few hours, the patient complained of para-abdominal pain and was investigated for a perforation.On (b)(6) 2018, after confirmation of a perforation in the proximal transverse colon, the patient was hospitalized and underwent a hemicolectomy and was treated with unspecified antibiotics.The physician felt that eleview contributed to the perforation.On "approximately" (b)(6) 2018, the patient was discharged and as of (b)(6) 2018, was making a full recovery.No additional information was provided.Company comment: keeping in mind the physician's data and opinion provided that eleview contributed by way of the technique of usage, the event of perforation is being reported during the use of eleview.Also, previous literature has suggested that submucosal agents are protective against perforations by actually providing a cushion type effect.The perforation is most likely due to a user error with the other equipment used (for example the snare) rather than the eleview itself.Event assessment: perforation - serious.Reportable.

• Brand Name: ELEVIEW
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): COSMO TECHNOLOGIES, LTD.; riverside ii; sir john rogerson's quay; dublin 2, D02KV 60; EI D02KV60
• Manufacturer Contact: valerie byrne ; riverside ii; sir john rogerson's quay; dublin 2, D02KV-60 ; EI D02KV60
• MDR Report Key: 8043353
• MDR Text Key: 126297310
• Report Number: 3012099114-2018-00001
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2018

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 Expiration Date: 06/01/2020
• Device Lot Number: UH143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CITALOPRAM 20 MG; DOXAZOSIN; LORATADINE (LORATADINE); LOSARTAN (LOSARTAN POTASSIUM); MULTIVITAMIN (DIETARY SUPPLEMENT); PRAVASTATIN (PRAVASTATIN); RANITIDINE (RANITIDINE); SAW PALMETTO (DIETARY SUPPLEMENT)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 111