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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER
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BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER Back to Search Results
Model Number SV-2101
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Pain (1994); Ulcer (2274); Discomfort (2330)
Event Date 12/12/2023
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Additionally, fiducial markers were placed.Post spaceoar vue placement procedure, the patient complained about abdominal pain.On (b)(6) 2023, the physician prescribed the patient an intra-anal pain medication.The patient's initial scans confirmed the correct hydrogel placement.However, the hydrogel started to move more posteriorly and in a strange shape in later images.On (b)(6) 2023, an additional computerized (ct) scan was performed and revealed that the hydrogel was not present in the implant area, there was a small amount of air where it used to be.On (b)(6) 2023, the patient was sent to a colorectal surgeon for further evaluation, and an ulcer was discovered.It was indicated that the patient was advised to use proctofoam during the start of his treatment, in the physician's assessment there is a possibility that the patient could have poked himself with the proctofoam insertion needle and this could have caused a hole.The patient's radiation treatment was paused as a result of these events.At the time of this report the patient is doing well with no bleeding and no pain or fever.It was indicated that another colonoscopy was scheduled to determine the appropriate treatment.The patient has gotten 27 fractions total out of 44.
 
Manufacturer Narrative
Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code e2330 is being used to capture the reportable event of pain.
 
Manufacturer Narrative
Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code e2330 is being used to capture the reportable event of pain.Blockh11: block d4 was corrected.
 
Event Description
It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Additionally, fiducial markers were placed.Post spaceoar vue placement procedure, the patient complained about abdominal pain.On (b)(6) 2023, the physician prescribed the patient an intra-anal pain medication.The patient's initial scans confirmed the correct hydrogel placement.However, the hydrogel started to move more posteriorly and in a strange shape in later images.On december 27, 2023, an additional computerized (ct) scan was performed and revealed that the hydrogel was not present in the implant area, there was a small amount of air where it used to be.On (b)(6) 2023, the patient was sent to a colorectal surgeon for further evaluation, and an ulcer was discovered.It was indicated that the patient was advised to use proctofoam during the start of his treatment, in the physician's assessment there is a possibility that the patient could have poked himself with the proctofoam insertion needle and this could have caused a hole.The patient's radiation treatment was paused as a result of these events.At the time of this report the patient is doing well with no bleeding and no pain or fever.It was indicated that another colonoscopy was scheduled to determine the appropriate treatment.The patient has gotten 27 fractions total out of 44.
 
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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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18820319
MDR Text Key336739514
Report Number2124215-2024-11347
Device Sequence Number1
Product Code OVB
UDI-Device Identifier00864661000140
UDI-Public00864661000140
Combination Product (y/n)N
PMA/PMN Number
K182971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/27/2024
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 NumberSV-2101
Device Catalogue NumberSV-2101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received03/28/2024
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 Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age82 YR
Patient SexMale
Patient Weight90 KG
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