MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE

Model Number M00562551

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  Injury  

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 Description

It was reported to boston scientific corporation that a profile small oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after opening and closing the device several times, the snare loop broke and fell off inside the patient.The broken snare loop was retrieved using graspers and the procedure was completed with another profile snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Event Description

It was reported to boston scientific corporation that a profile small oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after opening and closing the device several times, the snare loop broke and fell off inside the patient.The broken snare loop was retrieved using graspers and the procedure was completed with another profile snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: problem code 2907 captures the reportable event of snare loop detachment of device or device component.Block h10: (product investigation).One profile snare was received for analysis.Visual evaluation of the returned device revealed that the device has the loop detached.Inspection under microscope revealed that the loop cannula had evidence of crimp marks.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.Based on the information available and the analysis performed, the most probable cause for this complaint is adverse event related to procedure, due to the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: PROFILE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10662119
• MDR Text Key: 211091309
• Report Number: 3005099803-2020-04509
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729156659
• UDI-Public: 08714729156659
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: M00562551
• Device Catalogue Number: 6255
• Device Lot Number: 0025688169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention