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

Model Number M00561221

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The reported physician and healthcare facility is: (b)(6).(b)(4).The device has not been received for analysis; therefore, a problem 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 captivator ii-10mm round stiff snare was to be used to remove polyps in the intestinal tract during a polyp removal procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, it was noted that the sterile pouch was open and it was not sealed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used to remove polyps in the intestinal tract during a polyp removal procedure performed on (b)(6), 2021.It was reported that during preparation and outside the patient, it was noted that the sterile pouch was open and it was not sealed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported physician and healthcare facility is: (b)(6) block h6: problem code a020503 captures the reportable event of unsealed device packaging.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block h10 has been updated based on the additional information received on (b)(6) 2021 and the receipt of the complaint device for evaluation.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported physician and healthcare facility is: (b)(6).Block h6: problem code a020503 captures the reportable event of unsealed device packaging.Block h10: investigation results a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that the device was returned without the original pouch and no damage was found in the device.No other problems were noted.The reported event of "packaging no seal" was not confirmed since the original pouch was not returned and device analysis of the returned device found no problems with the device.Based on the information provided, without proper evaluation of the pouch, the most probable cause of the reported event cannot be established due to lack of evidence.The investigation findings do not lead to a clear conclusion about the cause of the reported event, therefore the most probable cause for this complaint 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.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used to remove polyps in the intestinal tract during a polyp removal procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, it was noted that the sterile pouch was open and it was not sealed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12469196
• MDR Text Key: 271325891
• Report Number: 3005099803-2021-04801
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0025620036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 58