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

Model Number M00561820

Device Problem Failure to Deliver Energy (1211)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a rotatable snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician tried to use the hot-cut using the electrosurgery equipment, it did not work.The snare's connection to the electrosurgery equipment did not work.The procedure was completed with another of the same device.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 stable.

Event Description

It was reported to boston scientific corporation that a rotatable snare was used during a colonoscopy procedure performed on 18nov2020.According to the complainant, during the procedure, when the physician tried to use the hot-cut using the electrosurgery equipment, it did not work.The snare's connection to the electrosurgery equipment did not work.The procedure was completed with another of the same device.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 stable.

Manufacturer Narrative

Block h6: problem code a090402 captures the reportable event of failure to deliver energy.Block h10: investigation results: a rotatable small 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 also performed and when the device was connected to the 10 inch loop fixture, the loop extended and contracted without issues.No other issues were noted.Media inspection revealed that the upn and lot number provided on the photo attached to the complaint matched with the reported information in this complaint.The reported event of failure to deliver energy was not confirmed since the analysis of the device found no issues were noted with the electrical device testing during continuity test upon return.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.Based on the analysis of the returned device and the information available, the code selected as the most probable cause in 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.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 10987758
• MDR Text Key: 220948079
• Report Number: 3005099803-2020-05902
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747703
• UDI-Public: 08714729747703
• Combination Product (y/n): N
• PMA/PMN Number: K992477
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: M00561820
• Device Catalogue Number: 6182S
• Device Lot Number: 0024167225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR