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

Model Number M00519510

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

Patient Problem Bowel Perforation (2668)

Event Date 03/27/2018

Event Type  Injury  

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 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
• Type of Device: TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7455203
• MDR Text Key: 106331180
• Report Number: 3005099803-2018-01258
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 08714729974604
• UDI-Public: 08714729974604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: M00519510
• Device Lot Number: 0000511507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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: 70 YR