MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

Procode: kns unit, electrosurgical, endoscopic.(b)(4).

Event Description

Per journal article: risk factors for serious adverse events associated with multiband mucosectomy in barrett¿s esophagus: an international multicenter analysis of 3827 endoscopic resection procedures.Belghazi et al.2020.Perforation - perforation occurred in 17 out of 3,827 procedures accounting for a perforation rate of 0.4% (95% ci, 0.3 ¿ 0.7) the vast majority of patients (14/17) could be treated endoscopically with clips (n=11) or a combination of clips and a stent (n=3).The endoscopically and conservatively treated patients were admitted for a median of 4 days (iqr 1 ¿ 5), and all cases were considered to be mild (n=7) or moderate (n=8) adverse events.In one patient clipping was not successful due to poor tissue grasping.This patient was therefore treated conservatively with antibiotics.Two patients ) were referred for surgery; both were graded as severe adverse events.In the first patient, er was performed because of a local recurrence after a large er.During the procedure, a perforation occurred within the previous er site.Because there was clear evidence of residual neoplasia, the decision was made to perform an emergency esophagectomy as local control of the disease was not achieved.In one patient clipping was not successful due to poor tissue grasping.This patient was therefore treated conservatively with antibiotics.Two patients) were referred for surgery; both were graded as severe adverse events.In the first patient, er was performed because of a local recurrence after a large er.During the procedure, a perforation occurred within the previous er site.Because there was clear evidence of residual neoplasia, the decision was made to perform an emergency esophagectomy as local control of the disease was not achieved.In the second patient, a perforation was observed immediately after the first resection.Because of the combination of residual neoplasia and periesophageal scarring after prior surgery for placement of an angelchik prosthesis, endoscopic treatment was not considered and the patient underwent an esophagectom.The data from this paper was obtained from 7 countries 7 countries ((b)(6), united states) as an exact location cannot be determine for the complaints, a complaint has been originated for each location.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10078586
• MDR Text Key: 193022852
• Report Number: 3005580113-2020-00363
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2020,05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• 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