Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORK LIMITED SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORK LIMITED SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER Back to Search Results
Model Number SO-2101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Pain (1994); Injury (2348)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(4) 2020.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.According to the complainant, an area of pus was seen near the perirectal fat in the anterior rectum.Colonoscopy was performed and it showed a potential fistula with pus.The physician concluded that the infection was possibly related to spaceoar.The patient was treated with 3 courses of broad spectrum antibiotics but the infection and fistula were still present.The patient received planned radiation therapy with 44 fractions.
 
Event Description
It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.According to the complainant, an area of pus was seen near the perirectal far in the anterior rectum.Colonoscopy was performed and it showed potential fistula with pus.The physician concluded that the infection was possibly related to spaceoar.The patient was treated with 3 courses of broad spectrum antibiotics but the infection and fistula were still present.The patient received planned radiation therapy with 44 fractions.On december 28, 2020, additional information received stating that the patient developed chronic perineal pain, and then frequency, urgency, and rectal pain.The patient has been on multiple antibiotics.Colonoscopy/anoscopy by the gastrointestinal (gi) tract was performed and it showed a small fistula in the anterior rectum that opens into a small pus-filled cavity in the space where the spaceoar normally sits.Cystoscopy was also performed and it showed nothing was communicating from the bladder into the anterior rectum.The fistula will be drained to the surface to the perineum.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2020.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: patient code 1930 captures the reportable event of infection.Patient code 1862 captures the reportable event of fistula.Patient code 1994 captures the reportable event of pain.Patient code 1690 captures the reportable event of abscess.Block h10: the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPACEOAR SYSTEM
Type of Device
ABSORBABLE PERIRECTAL SPACER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORK LIMITED
300 boston scientific way
marlborough MA 01752
MDR Report Key11066858
MDR Text Key223451167
Report Number3005099803-2020-06367
Device Sequence Number1
Product Code OVB
UDI-Device Identifier00864661000102
UDI-Public00864661000102
Combination Product (y/n)N
PMA/PMN Number
K181465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/22/2021
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 NumberSO-2101
Device Catalogue NumberSO-2101
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received12/28/2020
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-