MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ORISE TISSUE RETRACTOR; TISSUE RETRACTOR SYSTEM

Model Number	M00519510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an orise tissue retractor was used during a colonoscopy with endoscopic submucosal dissection procedure performed on (b)(6) 2018.Reportedly, the patient had a large polyp in the sigmoid colon approximately 30 cm from the anus, and the patient had a history of micro tears during previous polypectomy procedures.According to the complainant, during the procedure and prior to inserting the orise tissue retractor, a circumferential cut was made around the polyp.The orise tissue retractor was then introduced.When the device was expanded inside the patient, a micro-perforation was noted along the circumferential cut on the proximal right side.Antibiotics were administered and the procedure was completed with a snare.The perforation was repaired with a stitching device at the conclusion of the procedure.There were no patient complications at the conclusion of this procedure and the patient was reported to be fine.

• Brand Name: ORISE TISSUE RETRACTOR
• Common Device Name: TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7455203
• Report Number: 3005099803-2018-01258
• Device Sequence Number: 1097526
• Product Code: GAD
• UDI-Device Identifier: 08714729974604
• UDI-Public: 08714729974604
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: M00519510
• Device Lot Number: 0000511507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR