MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-06 for ELEVIEW manufactured by Cosmo Technologies, Ltd..
[126297310]
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.
Patient Sequence No: 1, Text Type: N, H10
[126297311]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012099114-2018-00001 |
| MDR Report Key | 8043353 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-06 |
| Date of Report | 2018-10-07 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-10-07 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VALERIE BYRNE |
| Manufacturer Street | RIVERSIDE II SIR JOHN ROGERSON'S QUAY |
| Manufacturer City | DUBLIN 2, D02KV60 |
| Manufacturer Country | EI |
| Manufacturer Postal | D02KV60 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVIEW |
| Generic Name | SUBMUCOSAL INJECTION AGENT |
| Product Code | PLL |
| Date Received | 2018-11-06 |
| Lot Number | UH143 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COSMO TECHNOLOGIES, LTD. |
| Manufacturer Address | RIVERSIDE II SIR JOHN ROGERSON'S QUAY DUBLIN 2, D02KV60 EI D02KV60 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-11-06 |