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

Model Number M00562691

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(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

It was reported to boston scientific corporation that a sensation small oval snare was prepared for use in the intestinal tract during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that the inner seal package was compromised.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a sensation small oval snare was prepared for use in the intestinal tract during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that the inner seal package was compromised.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Age or date of birth: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter address (b)(6).Problem code 1444 captures the reportable event of inner seal package compromised.Investigation results: visual evaluation of the returned device revealed that an open pouch was received and the sterile barrier was noted to be compromised, however, visual assessment does not have any anomalies.Evaluation of the returned device showed lack of evidence of the event which was failed to determine what could have contributed to the reported failure and does not lead to a clear conclusion of this issue, therefore, the most probable root cause classification 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.Manufacturer address and model number updated.

• 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: 7780752
• MDR Text Key: 117271478
• Report Number: 3005099803-2018-60014
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158158
• UDI-Public: 08714729158158
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Model Number: M00562691
• Device Catalogue Number: 50495
• Device Lot Number: 0020198085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1