MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESECTRTM TISSUE RESECTION DEVICE; HYSTEROSCOPE ACCESSORIES

Model Number	M0065907051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a resectr resecting device was used during a polypectomy procedure in the colon was performed on (b)(6) 2019.According to the complainant, during the procedure, the blade of the resecting device detached inside the patient while cutting and was removed using graspers.The procedure was completed with another resecting device.There were no serious injuries to the patient and the patient was reported to be fine after the procedure.
Event or Problem Description
It was reported to boston scientific corporation on july 16,2019 that a resectr resecting device was used during a polypectomy procedure in the colon was performed on (b)(6) 2019.According to the complainant, during the procedure, the blade of the resecting device detached inside the patient while cutting and was removed using graspers.The procedure was completed with another resecting device.There were no serious injuries to the patient and the patien was reported to be fine after the procedure.
Additional Manufacturer Narrative
Block g1: mfr site email: (b)(4).Block h6: device problem code 1069 captures the reportable event resecting device blade detached and retreived.Block h10: investigation results a cannula of a resectr device was returned for investigation.The handle had been cut away from the device prior to return.Visual inspection found that the blade was with a portion jammed exterior to the cutting window.The blade damage would have likely resulted in a failure to cut during the procedure, therefore confirming the event.Review and analysis of all available information indicated that the cannula was returned with a broken blade, this was likely a result of the device being used to cut calcified tissue and the device had no influence on the event.The dfu warns the user, movement of any resectr device against resistance may result in medical device damage, tissue perforation, or other injury.Therefore, the most probable root cause is adverse event related to procedure.A dhr (device history record) review was performed and the device met all manufacturing specifications.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

• Brand Name: RESECTRTM TISSUE RESECTION DEVICE
• Common Device Name: HYSTEROSCOPE ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8870594
• Report Number: 3005099803-2019-03991
• Device Sequence Number: 2206025
• Product Code: NWW
• UDI-Device Identifier: 08714729964537
• UDI-Public: 08714729964537
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 09/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: M0065907051
• Device Catalogue Number: 74088
• Device Lot Number: 0000118441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: 65 YR
• Patient Weight: 81