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

Model Number	M00562531
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported healthcare facility and physician information are: (b)(6).(b)(4).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.
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was to be used during a procedure on (b)(6) 2021.It was reported that, a dirt on the handle part found inside the sterile pouch was confirmed to have adhered before the package was opened.The procedure was completed with another profile snare.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was to be used during a procedure on (b)(6) 2021.It was reported that, a dirt on the handle part found inside the sterile pouch was confirmed to have adhered before the package was opened.The procedure was completed with another profile snare.***additional information received on (b)(6)2021*** per additional information, there was no patient involvement with this event.
Additional Manufacturer Narrative
Block e1: the reported healthcare facility and physician information are: (b)(6) block h6: problem code a180104 captures the reportable event of foreign material present on device.Block h10: investigation results a profile extra small oval flexible snare was received for analysis.The device was returned inside of the original and unopened pouch.Visual and microscopic inspection of the returned device revealed that it had a black stain in the handle, the stain was approximately 10 mm long.No other problems were noted.Device analysis found a black stain in the handle, confirming the reported event.Based on the information available and the analysis of the returned device, the most probable root cause for the reported complaint is manufacturing deficiency, due to evidence from the product analysis of a device problem.There is an investigation in place to address this problem.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: PROFILE
• Common Device Name: 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: 12675182
• Report Number: 3005099803-2021-05410
• Device Sequence Number: 1309591
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: 08714729156628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0027084970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown