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

Model Number SO-2101

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

Patient Problems Tachycardia (2095); Discomfort (2330); Loss of consciousness (2418); Diaphoresis (2452); Syncope/Fainting (4411)

Event Date 03/16/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2022.Additionally, the patient received a lidocaine block of about 15cc, and two fiducial markers.After the gel was placed and the procedure was completed the patient began to go in and out of consciousness.The patient's heart rate went up to 194, was sweating and coloring was off.The patient was admitted to the hospital for observation.The patient was admitted to hospital beyond the standard of care.The patient was reported to have fully recovered.

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

Corrected field: block h6: patient code e060109 tachycardia.Patient code e2310 diaphoresis.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 e9170 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.Block h11: the additional information received on april 6, 2022 update on: block b5 (incident narrative).Block h6 (patient codes).

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2022.Additionally, the patient received a lidocaine block of about 15cc, and two fiducial markers.After the gel was placed and the procedure was completed the patient began to go in and out of consciousness.The patient's heart rate went up to 194, was sweating and coloring was off.The patient was admitted to the hospital for observation.The patient was admitted to hospital beyond the standard of care.The patient was reported to have fully recovered.***additional information received on april 6, 2022*** the patient was lying down in recovery when the event occurred.In the physician's assessment, the cause of the loss of consciousness and elevated heart rate was a vasovagal event.The patient's blood pressure & heart rate was being monitored after the event.The patient was discharged from the hospital and appears to be in good health.

• Brand Name: SPACEOAR 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: 14048305
• MDR Text Key: 288875488
• Report Number: 3005099803-2022-01909
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• 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: 04/28/2022

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: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/28/2022
• 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): Other