MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562693

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensation short throw snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was inserted through the scope and the loop was extended, it was noted that the snare loop was broken.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Device problem code 1069 captures the reportable event of snare loop broken.Investigation results only the detached snare loop was returned for analysis and the rest of the device was not returned.A visual analysis of the returned device revealed that the snare was not broken along the loop.However, the entire loop was detached from the device.The snare loop had kinks and crimping marks were also noted.Since the rest of the device was not returned, based on the information available and the analysis performed, the most probable root cause is "cause not established." a review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a sensation short throw snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was inserted through the scope and the loop was extended, it was noted that the snare loop was broken.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8703343
• MDR Text Key: 148156226
• Report Number: 3005099803-2019-02962
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501671
• UDI-Public: 08714729501671
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: M00562693
• Device Catalogue Number: 6269-40
• Device Lot Number: 0023491285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1