MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE PROKNIFE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00519351

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

Patient Problem Perforation (2001)

Event Date 04/02/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. 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

Note: this report pertains to one of two devices used during the same procedure. It was reported to boston scientific corporation that an orise proknife and orise gel was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022. Near the end of the procedure, the patient coded. Code blue protocol was implemented and the patient was resuscitated. The patient was brought to surgery to repair a small perforation in the ascending colon, which was successfully treated with a clip. The patient decompensated over the next few days and died on (b)(6) 2022. The patient had multiple comorbidities and the family decided not to continue life support. No autopsy was performed, however the clinical cause of death was reported to be brain damage. The physician deemed the patient's death to be not related to the orise devices and probably related to the procedure.

• Brand Name: ORISE PROKNIFE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14256029
• MDR Text Key: 290441385
• Report Number: 3005099803-2022-02348
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1