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 Abdominal Pain (1685); Fever (1858); Fistula (1862); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Ulcer (2274); Swelling/ Edema (4577)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.Fiducial markers were placed during the same procedure.The patient received four treatments of standard fractionated intensity-modulated radiation therapy (imrt) a few weeks after the spaceoar procedure.The patient started complaining of pain in the abdominal area, swelling in the groin and testicular areas.The patient had multiple emergency room (er) visits and was diagnosed as septic.The physician evaluated the patient and was able to locate a large fistula starting in the rectum, through the prostate and into the bladder.The patient was treated with a permanent colostomy and was advised to undergo a colonoscopy.The patient was admitted to a hospital beyond the standard of care.The patient's outcome was reported to be disability and permanent damage.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 17jun2022.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date 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.Fiducial markers were placed during the same procedure.The patient received four treatments of standard fractionated intensity-modulated radiation therapy (imrt) a few weeks after the spaceoar procedure.The patient started complaining of pain in the abdominal area, swelling in the groin and testicular areas.The patient had multiple emergency room (er) visits and was diagnosed as septic.The physician evaluated the patient and was able to locate a large fistula starting in the rectum, through the prostate and into the bladder.The patient was treated with a permanent colostomy and was advised to undergo a colonoscopy.The patient was admitted to a hospital beyond the standard of care.The patient's outcome was reported to be disability and permanent damage.**additional information received on august 2, 2022.It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2022.The patient received four treatments of standard fractionated intensity-modulated radiation therapy (imrt) that started on (b)(6) 2022 and ended on (b)(6) 2022.For the last treatment, the patient complained about the pain he experienced in his scrotum.The physician review the cone-beam computed tomography systems (cbct) and found out that there was air in the patients bladder.The pain was predominately on the left side, when visually inspected it was inflamed and sensitive to touch.Physician advised the patient to go to the emergency room and was determined that the patient had an infection with fluid surrounding the left testicle and was sent home with antibiotics.The following week the pain had not subsided and the patient was re-admitted to the emergency room where it was determined the infection was septic.On (b)(6) 2022 the fluid was drained from his testicles and a rectal exam was performed.The colorectal surgeon felt a hole in the rectum that went through the prostate and into the bladder.Patient was scoped and the bladder was filled with cloudy urine and a fistula was confirmed.On (b)(6) 2022 a non reversible laparoscopic colonostomy was performed and a heavy course of antibiotics was prescribed.The patient was admitted to a hospital for three weeks before being discharged.The physician advised that there will be no longer additional radiation and to continue the hormone therapy.The physician said that there are no obvious signs that the gel was misplaced, it appears to be in the appropriate location.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h2: blocks a: patient information, b3, b5, b7 and d6a have been updated with the additional information received on august 2, 2022.Block h6: clinical code e2314 captures the reportable event of fistula.Clinical code e2339 captures the reportable event of ulcer.Clinical code e2330 captures the reportable event of pain.Clinical code e0306 captures the reportable event of sepsis.Clinical code e2326 captures the reportable event of unspecified infection.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.Block h11: correction to field d4: unique identifier.

• 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: 15100016
• MDR Text Key: 296562197
• Report Number: 3005099803-2022-03945
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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
• Date Manufacturer Received: 08/02/2022
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Black Or African American