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

Model Number UNK-P-ORISE_GEL

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

Patient Problems Muscle Spasm(s) (1966); No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that orise gel was used in the ascending colon, during an endoscopic mucosal resection (emr) procedure performed on an unknown date.According to the complainant, during procedure, it was observed that when the orise gel was injected, it caused colonic spasms in the right colon.The spasms were treated using glucagon and the procedure was completed using the original orise gel.No patient complications were noted, as a result of the colonic spasms.

Event Description

It was reported to boston scientific corporation that orise gel was used in the ascending colon, during an endoscopic mucosal resection (emr) procedure performed on an unknown date.According to the complainant, during procedure, it was observed that when the orise gel was injected, it caused colonic spasms in the right colon.The spasms were treated using glucagon and the procedure was completed using the original orise gel.No patient complications were noted, as a result of the colonic spasms.According to the physician, the colonic spasms must have been patient related and the orise gel was unrelated to the spasms.

Manufacturer Narrative

B5 and h6 patient code were updated.Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that orise gel was used in the ascending colon, during an endoscopic mucosal resection (emr) procedure performed on an unknown date.According to the complainant, during procedure, it was observed that when the orise gel was injected, it caused colonic spasms in the right colon.The spasms were treated using glucagon and the procedure was completed using the original orise gel.No patient complications were noted, as a result of the colonic spasms.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code 1966 captures the reportable event of "the orise gel caused colonic spasms" block h10: according to the complainant, the suspect device has been disposed 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
• MDR Report Key: 9157806
• MDR Text Key: 161718700
• Report Number: 3005099803-2019-04891
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• PMA/PMN Number: K180068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

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: UNK-P-ORISE_GEL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 10/10/2019
• Supplement Dates FDA Received: 10/10/2019; 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention