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

Model Number SV-2101

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

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907); Rash (2033); Renal Failure (2041); Movement Disorder (4412); Cough (4457)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on (b)(6) 2022.The procedure was performed under monitored anesthesia care (mac) with mild intravenous sedation with propofol.Two fiducial markers were placed prior to the implant procedure that reportedly went "very smoothly".Approximately three to five minutes after the conclusion of the procedure, the staff was helping the patient get dressed as he was waking up from mac sedation.The patient was sitting up, putting on his underwear and pants when "all of a sudden" he started to gurgle, cough, stopped breathing, became pulseless and went into cardiac arrest.The patient was reportedly in atrial fibrillation.It was noted he had no shortness of breath, no rash, and no warning before quickly becoming pulseless.The staff then began the code process.Cardiopulmonary resuscitation (cpr) was performed, and the patient started to spontaneously breathe at the facility.Emergency medical services (ems) arrived in less than five minutes to transport the patient to the hospital.The patient had one more arrest in the ambulance and then in the emergency room he arrested a third time.The patient was admitted to the hospital.He also had to go on dialysis temporarily.An echocardiogram was performed, on an unspecified date, which "looked good" and was normal.Following the initial report, an update on an unspecified date was received that the patient was in stable condition, but in the intensive care unit (icu) and was intubated.The patient's physician and anesthesiologist were under the assumption that the patient had an underlying heart condition that was not documented or communicated to the staff.The physician and staff did not reveal any inclination that they believed the incident was caused by the spaceoar hydrogel.There was nothing witnessed during the procedure that would have led them to believe the need was intervascular.The patient's son later, on an unspecified date, stated it was possible the patient had an allergy to "some kind of iodine" however there was no record of this.The hospital reportedly thought it was a possible allergic reaction.The patient, however, didn't present with typical allergic features as the symptoms came on with no warning.It was reported the patient did have a rash "eventually" when he got to the hospital.It went away quickly with intravenous solumedrol.It was noted that it was unclear which of the products the patient might have reacted to.It was also noted the patient had a fusion biopsy under anesthesia a "few months ago" in the same office.He would have received the same anesthesia including lidocaine to his skin and the same antibiotics.A possibility of having the patient sent to allergy to investigate the possibility of a polyethylene glycols (peg) allergy was raised, however it was not specified if this would occur.The patient also has a loop recorder that was placed "years ago" due to bradycardia.It hadn't been interrogated at all, so the patient's physician planned to suggest to his primary care provider that the loop recorder should be looked at.As of (b)(6) 2022, the patient was extubated and walking with a walker.As of the date of this report, the etiology of the event remained unknown.

• 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: 15589531
• MDR Text Key: 301597550
• Report Number: 3005099803-2022-05773
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• 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: 10/12/2022

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: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/12/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male