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

Model Number M00561223

Device Problem Failure to Cut (2587)

Patient Problems Pain (1994); Perforation (2001)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 captivator ii-10mm round stiff snare was used to remove a 7mm target polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the physician wanted to remove the 7mm target polyp using cold snaring.The nurse placed the snare around the polyp and tried to cut it off.Then the physician also tried to do so, but it did not work.They performed hot snaring immediately and after that, the ground looked okay.The procedure was completed by hot snaring with the same device.The patient experienced pain in the afternoon.Then a perforation was detected by staging ct the next day which showed the perforation.The patient underwent a surgical treatment to close the perforation.The patient was fine and was fully recovered.The patient was not hospitalized beyond the standard of care.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used to remove a 7mm target polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the physician wanted to remove the 7mm target polyp using cold snaring.The nurse placed the snare around the polyp and tried to cut it off.Then the physician also tried to do so, but it did not work.They performed hot snaring immediately and after that, the ground looked okay.The procedure was completed by hot snaring with the same device.The patient experienced pain in the afternoon.Then a perforation was detected by staging ct the next day which showed the perforation.The patient underwent a surgical treatment to close the perforation.The patient was fine and was fully recovered.The patient was not hospitalized beyond the standard of care.

Manufacturer Narrative

Block e1 (initial reporter phone): (b)(6).Block h6: problem code a050702 captures the reportable event of snare loop cutting issues.Patient code e2330 captures the reportable event of pain.Patient code e2114 captures the reportable event of perforation.Block h10: investigation results: a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no damages were found.During functional inspection, the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.Continuity test was performed and the device passed, indicating a proper connection.No other problems were noted.Photos were provided by the physician and the images showed anatomical pictures (polyp), also the other pictures showed a section of the device, however the picture was not of good quality to assess a device problem.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported issues of "perforation and pain" could not be confirmed as the alleged problems were related to patient condition.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 problems with the device during visual, electrical and functional test.The reported events of perforation and pain are known events defined in the product's risk management documentation.Based on the information available and the returned device analysis, 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 instructions for use (ifu) / product label.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12384514
• MDR Text Key: 268692771
• Report Number: 3005099803-2021-04379
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: 08714729861317
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0027312870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention