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

Model Number	M00519510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bowel Perforation (2668); No Code Available (3191)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an orise tissue retraction system was used in the rectal/sigmoid region of the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2018.Reportedly, the device was being used to resect a 4 cm flatter lesion that tested positive for high-grade dysplasia (hgd) on biopsy.According to the complainant, during the procedure and prior to inserting the orise device, a circumferential mucosal cut was made and approximately 30% of the lesion was dissected using traditional esd methods.The orise device was then inserted to visualize the lesion and was pushed through the portion of the lesion that had been dissected, causing a perforation.Reportedly, the physician may have "pushed too hard" when inserting the device.The perforation was treated by laparoscopically performing a rectal sigmoid resection, removing the lesion and the perforation, and connecting the anastomosis.There have been no further patient complications as a result of this event.The patient's condition was reported to be fine.

• Brand Name: ORISE
• Common Device Name: TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 7838696
• Report Number: 3005099803-2018-60233
• Device Sequence Number: 1517468
• Product Code: GAD
• UDI-Device Identifier: 08714729974604
• UDI-Public: 08714729974604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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 Model Number: M00519510
• Device Catalogue Number: 51299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/31/2018
• 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