MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT

Model Number M00519201

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

Patient Problems Scar Tissue (2060); Fibrosis (3167)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a patient was injected with orise gel in the rectum during a procedure on an unknown date.Post-procedure, significant tissue scarring and fibrosis occurred.The physician believes the orise is scarring the tissue post-procedure.On (b)(6) 2022, the patient went to surgery for their disease.During that endoscopic submucosal dissection procedure for resection of cancerous lesion, it was noted that the orise gel had hardened so much tissue that they had to "upgrade" the surgery to excise more tissue than originally needed.The patient was not admitted to the hospital beyond the standard of care.Following the procedure, the patient outcome was reported to be "fully recovered".

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device is implanted and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: ORISE GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; business & technonlogy park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13563905
• MDR Text Key: 287526177
• Report Number: 3005099803-2022-00865
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00519201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/18/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention