MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SENSATION¿ SHORT THROW; SNARE, FLEXIBLE

Model Number M00562671

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, 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 mdr will be filed.

Event Description

Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-00997 for the other associated device information.It was reported to boston scientific corporation that two sensation medium oval snares were prepared for use during a polypectomy procedure.According to the complainant, during preparation, the cautery pin was detached.The procedure was completed with another sensation 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 good.

Manufacturer Narrative

Investigation results visual evaluation of the returned device found no anomalies and the cautery pin was noted to be in good condition.Dimensional analysis revealed that the device passed the gauge test.Evaluation of the returned device found no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) was performed and no deviations were found.

Event Description

Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-00997 for the other associated device information.It was reported to boston scientific corporation that two sensation medium oval snares were prepared for use during a polypectomy procedure.According to the complainant, during preparation, the cautery pin was detached.The procedure was completed with another sensation 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 good.

• Brand Name: SENSATION¿ SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7379157
• MDR Text Key: 103801604
• Report Number: 3005099803-2018-00996
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158141
• UDI-Public: 08714729158141
• Combination Product (y/n): N
• PMA/PMN Number: K941750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0021295215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1