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

Model Number M00561221

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.This event was reported by the clinical engineering manager.The reported healthcare facility is: (b)(6).(b)(6) adverse incident report reference no (b)(4); submitted to (b)(6) by the clinical engineering manager.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 captivator ii snare was used during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure, whilst removing a polyp, the patient seemed to get an electric shock with localized pain at the site of the polyp.They had used the snare previously with polyps and there was no issue.They checked all connections from the erbe, ensuring the pad was correctly applied.The site of polypectomy was observed to ensure no perforation had occurred.All connections on the diathermy machine were good and the indicators were green meaning a good circuit was present.The procedure was completed with a non bsc device.The pain was reported to have settled after 30 seconds and the patient was noted to be fine following the procedure.The patient was discharged at 17:10.At 17:45 the patient rang the department stating she had abdominal pain.The physician then suggested that the patient go to a&e.It was reported that it had been noticed that the patient had not attended.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: CAPTIVATOR II
• Type of Device: 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: 12467783
• MDR Text Key: 271429598
• Report Number: 3005099803-2021-04734
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other