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

Model Number UNK-P-SPACEOAR

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

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Ischemia (1942); Necrosis (1971); Ulcer (2274); Discomfort (2330); Constipation (3274)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "ischemic proctitis after low-dose-rate brachytherapy using hydrogel spacer for prostate cancer".It was reported to boston scientific corporation that an unknown spaceoar device was implanted during a spaceoar implant procedure on an unknown date.It was noted spaceoar implant occurred two months after beginning low-dose-rate (ldr) brachytherapy.Two months after ldr brachytherapy, the patient was hospitalized for nineteen days due to constipation and melena.Additionally, the patient experienced abdominal pressure due to constipation.The constipation lasted for two weeks prior to hospitalization and had not improved with laxatives.Contrast-enhanced computed tomography was performed which indicated possible proctitis.A colonoscopy was also performed which revealed localized longitudinal rectal ulcers.A stool culture, while hospitalized, was positive for methicillin-resistant staphylococcus aureus and escherichia coli.The patient's c-reactive protein was found to be high at 10.57 mg/dl and the serum procalcitonin was low at 0.06 ng/ml, which was reported to have excluded infectious disease as a diagnosis.The patient was diagnosed with ischemic proctitis.A rectal biopsy confirmed active ulcer with necrotic tissue.The patient was treated with fasting for eight days, and cefmetazole for ten days was administered to prevent secondary infection.Two weeks after the patient was hospitalized, an endoscopy was performed, which revealed ulcer improvement.It was reported the patient made a complete recovery.The patient received ldr brachytherapy combined with 6 months of androgen deprivation therapy (adt).The prescribed radiation dose was 145 gy.

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2022, was chosen as the literature article was submitted for publication on 02/17/2022.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Literature source: toriumi r, yaegashi h, sakurai t et al.Ischemic proctitis after low-dose-rate brachytherapy using hydrogel spacer for prostate cancer.Iju case rep.2022; https://doi.Org/ 10.1002/iju5.12444.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 15371965
• MDR Text Key: 299406384
• Report Number: 3005099803-2022-04983
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

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: UNK-P-SPACEOAR
• Device Catalogue Number: UNK-P-SPACEOAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/07/2022
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male