MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

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

Patient Problem Stenosis of the esophagus (4487)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.(b)(4).

Event Description

Spadaccini et al 2019 (duette) ¿ ¿multi-band mucosectomy for neoplasia in patients with barrett¿s esophagus: in vivo comparison between two different devices¿.Our aim was to evaluate and com-pare the efficacy, safety & histological characteristics of resected specimen with the two devices available for mbm (duette¿-cookmedical, limerick, ireland; captivator¿¿boston scientific corporation, natick, ma, usa).After marking, the endoscope was removed and the mbm system was loaded.Mbm was performed by using the due or capt mbm systems.The two devices consist of a trans-parent cap with six rubber bands and a releasing system assembled onto the endoscope before its re-introduction.The mucosa to be resected was sucked into the banding cap and the ligation rubber band was released creating a pseudopolyp.A braided snare was introduced, closed beneath the rubber band, and the pseudopolyp was resected (forced coagulation 40 w;erbe).Up to six subsequent resections were performed without extracting the scope according to lesion size and morphology.2 patients in the duette group developed a symptomatic stricture requiring treatments: patients required endoscopic dilation (either pneumatic or mechanical), but 1 required surgery for refractory stenosis.This file will capture the potential that this event occurred in italy, pr (b)(4) will capture the potential that this event occurred in (b)(6).

Manufacturer Narrative

Device evaluation: the duette multi-band mucosectomy device of unknown lot number and rpn involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the attached journal article.¿multi-band mucosectomy for neoplasia in patients with barrett¿s esophagus: in vivo comparison between two different devices¿ document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Th instructions for use possible for this device, ifu0029-10 which would accompany this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks¿ it should be noted that stricture formations are a known contraindication stated in the instructions for use (ifu0029-10) ¿contraindications specific to esophageal banding include, but are not limited to: cricopharyngeal or esophageal narrowing or stricture¿ the instructions for use also state strictures are potential complications ¿potential complications associated with emr include, but not limited to: esophagel perforation, stricture formation¿.76 patients were involved in this study, broke into groups of 38 patients.According to the information received the duette multi-band mucosectomy device was used in the 38 patients.2 of 38 patients in the duette group developed a symptomatic stricture.According to our clinical advisor the stricture formation adverse effects described in the attached paper were a result of the mucosectomy and the device did cause or contribute to this complaint.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to the pre-existing condition barrett¿s esophagus.Summary: the complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11639597
• MDR Text Key: 261767195
• Report Number: 3001845648-2021-00283
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male