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 Apnea (1720); Cardiac Arrest (1762); Loss of consciousness (2418); Diminished Pulse Pressure (2606); Syncope/Fainting (4411)

Event Date 05/25/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2022.The procedure was performed under local anesthesia.After the hydrogel was placed, the patient passed out from the rectal pressure on the nerves.The patient was non responsive.Cardiopulmonary resuscitation (cpr) was administered.The patient was transferred to the emergency department (ed) and was intubated.The patient also tested positive for covid-19 again.On (b)(6) 2022 the patient was extubated, and released.

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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: clinical code e0119 captures the reportable event of loss of consciousness.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Correction: it was noticed on june 23, 2022, that the following patient codes 9235: pulse, loss of and 9018: apnea was not included in the initial mdr report.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2022.The procedure was performed under local anesthesia.After the hydrogel was placed, the patient passed out from the rectal pressure on the nerves.The patient was non responsive.Cardiopulmonary resuscitation (cpr) was administered.The patient was transferred to the emergency department (ed) and was intubated.The patient also tested positive for covid-19 again.On (b)(6) 2022 the patient was extubated, and released.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: clinical code e0119 captures the reportable event of loss of consciousness.Block h11: block h6 patient and impact codes have been corrected.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2022.The procedure was done under local anesthesia.It was reported that after the gel was placed, the patient passed out from the rectal pressure on the nerves.The patient was non responsive.Cardiopulmonary resuscitation (cpr) was administered.The patient was transferred to the emergency department and was intubated.The patient also tested positive for covid-19 again.The patient was extubated on (b)(6) 2022, and had already been released.

• 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: 14718991
• MDR Text Key: 294542612
• Report Number: 3005099803-2022-03317
• 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,Followup
• Report Date: 06/13/2023

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: 05/25/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/23/2022; 06/13/2023
• Supplement Dates FDA Received: 07/19/2022; 06/13/2023
• 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): Other