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

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Ulcer (2274); Urinary Frequency (2275)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Medical device problem code: (b)(4).Patient code: (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.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on an unknown date.The procedure was done under local anesthesia.After spaceoar vue placement, the patient presented with elevated prostate specific antigen (psa), noturia and urinary frequency.The patient noted having 7 days of rectal bleeding.The bleeding was 2 to 10ml, 2 to 4 times a day or shortly after bowl movements.The bleeding subsided after holding the patient's alleve for 5 days.After the bleeding subsided, the patient experienced pain at 3 to 8 out of 10 with bowl movement and pain when resting at 3 out of 10.The patient received 50 mg tramadol.On (b)(6) 2022, magnetic resonance imaging (mri) performed and shows a small amount of gel in the rectal wall.A tiny channel of gel from the anterior portion of the rectum along the superior aspect of the rectum was noted.This indicated a small ulceration.The patient completed radiation treatment and was reported to be doing well.

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: 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.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on an unknown date.The procedure was done under local anesthesia.After spaceoar vue placement, the patient presented with elevated prostate specific antigen (psa), nocturia and urinary frequency.The patient noted having 7 days of rectal bleeding.The bleeding was 2 to 10ml, 2 to 4 times a day or shortly after bowl movements.The bleeding subsided after holding the patient's alleve for 5 days.After the bleeding subsided, the patient experienced pain at 3 to 8 out of 10 with bowl movement and pain when resting at 3 out of 10.The patient received 50 mg tramadol.On (b)(6) 2022, magnetic resonance imaging (mri) performed and shows a small amount of gel in the rectal wall.A tiny channel of gel from the anterior portion of the rectum along the superior aspect of the rectum was noted.This indicated a small ulceration.The patient completed radiation treatment and was reported to be doing well.Additional information received on march 21,2022: the patient complications resolved over time.The gel misplacement was reportedly not confirmed.

• 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: 13956506
• MDR Text Key: 288285702
• Report Number: 3005099803-2022-01647
• 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: 04/13/2022

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?: Yes
• 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: 03/04/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/13/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White