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 Arrhythmia (1721); Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Rash (2033); Diminished Pulse Pressure (2606)

Event Date 09/27/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure under general anesthesia, on (b)(6) 2022.The spaceoar vue placement procedure was performed without complications.At the end of the procedure when the anesthesiologist moved to intubate the patient, the patient's pressure dropped to 42/29, and he went into ventricular tachycardia.At that point, the patient did not have a pulse at all.Cardiopulmonary resuscitation (cpr) was required, they gave him epinephrine and chest compressions for about five or ten minutes and eventually the patient came back into sinus rhythm.The interventional cardiologist performed an urgent echography, the myocardium was fine, and the ejection fraction (ef) was fifty percent.Tha patient was noted to have a full-blown maculopapular rash from the neck all the way down to the groin.In the physician assessment, the patient experienced an anaphylactic reaction.During the case the patient was treated with ancef, xylocaine (4cc) to the perineum, and anesthesia maintained him on propofol and versed.The physician used betadine (10cc) to prep the perineal area.The patient was reported to be fully recovered in the intensive care unit (icu).The patient's blood pressure was back to normal.The patient's rash has totally disappeared and is gone.Boston scientific has been unable to obtain more details despite of the good faith efforts.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

Manufacturer Narrative

Corrected fields: block h6 (patient codes): ar codes 9139: hypotension and 9235: pulse, loss of, were added.Ar code 9254: shock, hypovolemic was removed.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e1714 captures the reportable event of rash.Patient code e0402 captures the reportable event of hypersensitivity/allergic reaction.Patient code e1714 captures the reportable event of arrhythmia.Patient code e0609 captures the reportable event of pulse, loss of.Patient code e1714 captures the reportable event of cardiac arrest.Patient code e2321 captures the reportable event of hypotension.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure under general anesthesia, on (b)(6) 2022.The spaceoar vue placement procedure was performed without complications.At the end of the procedure when the anesthesiologist moved to intubate the patient, the patient's pressure dropped to 42/29, and he went into ventricular tachycardia.At that point, the patient did not have a pulse at all.Cardiopulmonary resuscitation (cpr) was required, they gave him epinephrine and chest compressions for about five or ten minutes and eventually the patient came back into sinus rhythm.The interventional cardiologist performed an urgent echography, the myocardium was fine, and the ejection fraction (ef) was fifty percent.The patient was noted to have a full-blown maculopapular rash from the neck all the way down to the groin.In the physician assessment, the patient experienced an anaphylactic reaction.During the case the patient was treated with ancef, xylocaine (4cc) to the perineum, and anesthesia maintained him on propofol and versed.The physician used betadine (10cc) to prep the perineal area.The patient was reported to be fully recovered in the intensive care unit (icu).The patient was intubated.The patient's blood pressure was back to normal.The patient was responding and gave a thumbs up.The patient's rash had totally disappeared and was gone.

• 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: 15643369
• MDR Text Key: 302163803
• Report Number: 3005099803-2022-06169
• 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,Followup
• Report Date: 11/18/2022

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: 09/27/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male