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

Model Number M00561831

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) captures the reportable event of snare loop cutting issue.(b)(4) captures the reportable event of device failure to deliver energy.(b)(4) captures the reportable event of perforation.The device has not been received for analysis; therefore, a failure 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 rotatable medium oval med stiff snare was to be used to remove a 1cm polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the surgeon felt that the snare did not cut or sear the tissue which caused minimal bleeding.There was no visible issue noted with the cautery pins; they were in place, cord was connected appropriately, and no other issues were noted with the device.Reportedly, there was an attempt to cauterize the target polyp.The procedure was completed with another rotatable snare.The patient's minimal bleeding resolved on its own; however, the patient had to come back to the or the following day for a perforation at that site.Although the patient condition following the procedure was reported to be stable, details regarding the patient's perforation is unknown.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting issue.Problem code a090402 captures the reportable event of device failure to deliver energy.Problem code a150201 captures the reportable event of snare loop entrapment.Patient code e2114 captures the reportable event of perforation.Block h10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, h2 and h6 (device codes and impact codes) have been updated based on the additional information received on june 22, 2021.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was to be used to remove a 1cm polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the surgeon felt that the snare did not cut or sear the tissue which caused minimal bleeding.There was no visible issue noted with the cautery pins; they were in place, cord was connected appropriately, and no other issues were noted with the device.Reportedly, there was an attempt to cauterize the target polyp.The procedure was completed with another rotatable snare.The patient's minimal bleeding resolved on its own; however, the patient had to come back to the or the following day for a perforation at that site.Although the patient condition following the procedure was reported to be stable, details regarding the patient's perforation is unknown.Additional information received on june 22, 2021.It was reported that the snare would not close on a 1cm target polyp and the snare loop was stuck on the polyp.Additionally, it was reported that it took a fair bit of movement to finally get the snare off the base of the polyp.Once the snare was removed from the polyp, the new snare worked fine.They had already changed out the electrocautery cables and made sure all connections were good before they changed out the snare.The surgeon could see a pulsatile vessel at the base of the area of the polypectomy and placed one clip over it.Reportedly, at the time the surgeon did not think there was a perforation.The patient came to the er the following day with a perforation which was at the site of the polypectomy when she underwent a laparotomy and repair.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was to be used to remove a 1cm polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the surgeon felt that the snare did not cut or sear the tissue which caused minimal bleeding.There was no visible issue noted with the cautery pins; they were in place, cord was connected appropriately, and no other issues were noted with the device.Reportedly, there was an attempt to cauterize the target polyp.The procedure was completed with another rotatable snare.The patient's minimal bleeding resolved on its own; however, the patient had to come back to the or the following day for a perforation at that site.Although the patient condition following the procedure was reported to be stable, details regarding the patient's perforation is unknown.Additional information received on june 22, 2021: it was reported that the snare would not close on a 1cm target polyp and the snare loop was stuck on the polyp.Additionally, it was reported that it took a fair bit of movement to finally get the snare off the base of the polyp.Once the snare was removed from the polyp, the new snare worked fine.They had already changed out the electrocautery cables and made sure all connections were good before they changed out the snare.The surgeon could see a pulsatile vessel at the base of the area of the polypectomy and placed one clip over it.Reportedly, at the time the surgeon did not think there was a perforation.The patient came to the er the following day with a perforation which was at the site of the polypectomy when she underwent a laparotomy and repair.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting issue.Problem code a090402 captures the reportable event of device failure to deliver energy.Problem code a150201 captures the reportable event of snare loop entrapment.Patient code e2114 captures the reportable event of perforation.Block h10: investigation results a rotatable medium oval med stiff snare was received for analysis.Visual inspection of the returned device revealed no issues were noted.Continuity test was performed and the device's electrical resistance was within specification, indicating a proper connection.Functional inspection was performed.The device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.No other issues were noted.The reported event of "device failure to deliver energy" was not confirmed since the device passed the continuity test upon return.The reported event of "loop failure to cut" and "loop entrapment of device or device component" were unable to be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "perforation" and "hemorrhage" were also unable to be confirmed as these events are related to the patient condition, however, they are known and documented in the labeling.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 issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual and functional test.No issues were noted with the electrical device testing during continuity test.The reported events of "perforation" and "hemorrhage" are known and documented in the labeling, therefore are assigned the most probable cause of known inherent risk of device.Based on the information available and the analysis of the returned device, the most probable root cause for the reported complaint is no problem detected.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12041067
• MDR Text Key: 257430712
• Report Number: 3005099803-2021-02915
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (y/n): N
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0026935438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR