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

Model Number M00561221

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter address is (b)(6).The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and 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 10mm round stiff captivator snare was prepared for use during a procedure performed on an unknown date.According to the complainant, a strand of hair was found inside the sterile unopened pouch.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a 10mm round stiff captivator snare was prepared for use during a procedure performed on an unknown date.According to the complainant, a strand of hair was found inside the sterile unopened pouch.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: the initial reporter address is (b)(6).Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2969 captures the reportable event of device contaminated during manufacture or shipping.Block h10: one captivator ii-10mm round stiff snare was received for analysis.Visual evaluation of the complaint device noted a strand of hair inside the sealed package.A risk review of the cold snare was completed using polypectomy snares risk management workbook and confirmed that the event of foreign matter was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• 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: 9935062
• MDR Text Key: 191420096
• Report Number: 3005099803-2020-01518
• 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
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0023880107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1