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 Bradycardia (1751); Cardiac Arrest (1762); Nausea (1970); Dizziness (2194); Loss of consciousness (2418); Diminished Pulse Pressure (2606); Syncope/Fainting (4411)

Event Date 03/02/2023

Event Type  Death  

Manufacturer Narrative

Block b3: the complainant reported the approximate procedure and death date of the event was on march 02, 2023.Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: impact code f02 captures the reportable event, death.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was used during a spaceoar vue implant procedure on an unknown date, approximated to be four weeks before boston scientific corporation became aware of the event.The patient was given antibiotics before and after the procedure (keflex / cephalexin 1 tablet in the morning and one ablet in the evening).The patient was also given a prescription of norco (hydrocodone/acetaminophen 5/325 mg), 0.5mg ativan (taken 1 hour prior to procedure) before procedure.The skin was sprayed with ethyl chloride spray, and the injection area was cleaned with chlorhexidine prep before injecting lidocaine.The procedure was performed under local anesthetic (2% lidocaine 8-9mltotal; 2ml were placed under the skin, the rest was placed at apex of prostate), followed by hydro-dissection with 2-3 ml of saline, and aspiration was performed and confirmed there was no blood (the needle was in the right place).The hydrogel was placed under ultrasound guidance with urojet lidocaine gel in the rectum.After the injection of the hydrogel the stepper probe was removed, the patients' legs were lowered, and the patient was instructed to stay laying down to avoid being lightheaded.After 10-15 seconds the patient said that he was lightheaded.Ten (10) seconds later the patient rolled to his side and attempt to vomit, dry heaved, then the patient laid back down and said he wasn't feeling ok.The patient dried heaved again and laid down.The patient was cyanotic, and lost consciousness.It was reported the patient was breathing but was not responsive, rapid response turned into code blue, the patient was intubated and was injected with epinephrine and sodium bicarbonate.Cardiopulmonary resuscitation was performed for 20 minutes and since there was no shockable rhythm the patient was never shocked.The patient was then pronounced dead.An autopsy was performed and reported the cause of death as natural causes due to hypertensive atherosclerotic cardiac disease.

• 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: 16765211
• MDR Text Key: 313537059
• Report Number: 3005099803-2023-02016
• 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: 04/18/2023

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
• 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: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White