MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER

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

Patient Problems Abscess (1690); Diarrhea (1811); Flatus (1865); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Dysuria (2684); Fluid Discharge (2686); Constipation (3274); Decreased Appetite (4569); Fecal Incontinence (4571)

Event Date 12/21/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an unknown spaceoar device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2022.After spaceoar placement the patient experienced bright color red bleeding, dysuria, constipation, diarrhea, discomfort, abdominal pressure, loss of appetite, and uncontrolled bowel movements with an increasingly worsening and with no consistent relief.The patient also experienced abdominal and rectal pain; severe inflammation and pain in the rectal area were also noticed.The patient bowel movements presented mucous.As a result of the patient's pain and constant bowel movements, the patient experienced depression.It was reported that the patient developed an abscess.On (b)(6) 2023, the patient experienced pain in the rectal area, frequent gas, and feeling like he had to have bowel movements.The patient was treated with amusol-hc cream.On (b)(6) 2023, the patient went to the emergency room (er) due to rectal pain and scant bowel movements for almost three weeks.Lower quadrant abdominal tenderness was also reported, the patient was diagnosed with possible prostatitis and was treated with amoxicillin 875/125 bid for 10 days.A computerized tomography (ct) scan was performed with and without contrasts to the abdomen/ pelvis, and inflammation in the patient's rectum was noticed.On (b)(6) 2023, the patient was treated with a solumedrol dose pack for rectal symptomology.Approximately on (b)(6) 2023, the patient received a digital rectal exam (dre).On (b)(6) 2023, the patient underwent a pelvic magnetic resonance imaging (mri) with and without contrast.On (b)(6) 2023, the patient underwent a sigmoidoscopy.On (b)(6) 2023, the patient was diagnosed with an abscess and was prescribed with cipro-hcl 500 milligrams (mg), and mesalamine 1000 mg rectal suppository.The patient's radiation treatment was completed.External beam radiation treatment was noted.

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code e2326 captures the reportable event of inflammation.Patient code e2330 captures the reportable event of pain.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16495497
• MDR Text Key: 310794152
• Report Number: 3005099803-2023-01078
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• 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: 03/07/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/07/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male