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

Model Number M00561221

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was noted to have a foreign material during routine check on february 8, 2023.During routine check of equipment, the nurse noted a hair inside unopened, sterile pouch of the device.The seal package was not compromised and there was no damage noted to the inner sterile pouch.There patient was not in the room when the event occurred.There was no patient involvement.

Manufacturer Narrative

Imdrf device code a180104 captures the reportable event of foreign material found in device.

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material found in device.Block h10 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found a hair inside the pouch.No other device problems were noted.The reported event of "foreign material present in device" since it was observed that a hair was found inside the pouch.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Visual analysis found a hair inside the pouch.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.Block g2: "report source (other) has been corrected.".

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was noted to have a foreign material during routine check on (b)(6) 2023.During routine check of equipment, the nurse noted a hair inside unopened, sterile pouch of the device.The seal package was not compromised and there was no damage noted to the inner sterile pouch.There patient was not in the room when the event occurred.There was no patient involvement.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16495104
• MDR Text Key: 310787801
• Report Number: 3005099803-2023-01020
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0029348507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1