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

Model Number SV-1010

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

Patient Problems Abscess (1690); Fever (1858); Unspecified Infection (1930); Urinary Retention (2119); Decreased Appetite (4569)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021.The procedure was done under general anesthesia.The procedure was done via remote support with the spaceoar training manager.According to physician standard surgical precautions, drapes, skin disinfection, prophylactic ciprofloxacin were taken as per protocol and no issues or concerns during the case.On (b)(6) 2021, the patient was presented with loss of appetite and fever.During radiation treatment, the patient developed increasing lower urinary tract symptoms and acute urinary retention after 11 of planned 20 treatments.His radiation treatment was put on hold.Diagnostic computerized tomography (ct) scan was performed and it showed a pelvice collection in the perineum and extending in continuity to the spacer.No bowel symptoms to report.In the physician's assessment, it was likely that the infection/abscess was related to the spaceoar procedure.The urinary retention, loss of appetite, fever, pelvic collection, and increasing lower urinary tract symptoms were caused by perineal abscess patient was hospitalized.He was put on intravenous (iv) antibiotics and was catheterized.He was also scheduled for radiological drainage on (b)(6) 2021.Additionally, patient had incision and drainage, and clinically has improved.He now has regular dressing changes of his perineal wound.Radiation has not been able to resume as yet but was planned to do so in a few weeks time.

• Brand Name: SPACEOAR VUE 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: 11777271
• MDR Text Key: 249051054
• Report Number: 3005099803-2021-01769
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2021

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: SV-1010
• Device Catalogue Number: SV-1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/05/2021
• 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): Other
• Patient Age: 67 YR