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

Model Number	M00562551
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 small oval flexible snare was used in the bile duct for stent removal during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the stent removal procedure, the snare loop broke.The procedure was completed with another snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: it was reported that the physician went to do a stent pull with a profile snare.However, per the instructions for use (ifu), the single-use polypectomy snares are indicated for use in the removal and cauterization of diminutive polyps, sessile polyps, and pedunculated polyps.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of loop broken.Block h10: (product investigation) one profile snare was received for analysis.The loop was not returned.Visual analysis of the returned device noted that the working length was kinked in the distal side and loop was detached from the device (the loop was not returned) which was confirmed under microscope.It was also noted that the loop cannula had evidence of torque marks (evidence of the loop was attached to the device).In the photo, it was possible to see a segment of the loop detached inside of the body.Functional evaluation of the returned device could not be performed due to the condition of the returned complaint device.The reported event of "loop detached" was confirmed since the device's loop was detached from the device and not returned.It was reported that the snare was used to remove a stent during the procedure.Therefore, this device was not used in a manner consistent with the instructions for use (ifu)/label.The ifu cites:"the single-use polypectomy snares are indicated for use endoscopically for the removal and or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract." this may have resulted in the reported event.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is unintended use error caused or contributed to event.This code was selected since an interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a profile small oval flexible snare was used in the bile duct for stent removal during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During the stent removal procedure, the snare loop broke.The procedure was completed with another snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: it was reported that the physician went to do a stent pull with a profile snare.However, per the instructions for use (ifu), the single-use polypectomy snares are indicated for use in the removal and cauterization of diminuitive polyps, sessile polyps, and pedunculated polyps.

• 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: 13125005
• Report Number: 3005099803-2021-08091
• Device Sequence Number: 4627421
• Product Code: FDI
• UDI-Device Identifier: 08714729156659
• UDI-Public: 08714729156659
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 07/13/2024
• Device Model Number: M00562551
• Device Catalogue Number: 6255
• Device Lot Number: 0027665019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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