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

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/11/2020

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.(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 (b)(6) 2020.Reportedly, fiducials were administered transperineal prior to spaceoar implantation and the procedure was done with no anesthesia.Additionally, saline was injected in the rectal wall during hydrodissection.According to the complainant, the patient experienced discomfort and pain days after the procedure prior to radiation therapy.Magnetic resonance imaging (mri) for radiation treatment was performed and it showed that the gel infiltrated the rectal wall.Reportedly, 10cc of the hydrogel was noted to be in the rectal wall.The physician concluded that the discomfort and pain were due to the spaceoar being present in the rectum.The patient described pain in rectum, exactly where spaceoar was placed.The patient was treated with percocet.Reportedly, the patient pain was slowly improving.The patient will receive external beam radiation therapy (ebrt) 60/20 fractions.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2020.Reportedly, fiducials were administered transperineally prior to spaceoar implantation and the procedure was done with no anesthesia.Additionally, saline was injected in the rectal wall during hydrodistention.According to the complainant, the patient experienced discomfort and pain days after the procedure prior to radiation therapy.Magnetic resonance imaging (mri) for radiation treatment was performed and it showed that the gel infiltrated the rectal wall.Reportedly, 10cc of the hydrogel was noted to be in the rectal wall.The physician concluded that the discomfort and pain were due to the spaceoar.The patient described pain in rectum, exactly where spaceoar was placed.The patient was treated with percocet.Reportedly, the patient pain was slowly improving.The patient will receive external beam radiation therapy (ebrt) 60/20 fractions.

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: device code 3009 captures the reportable event of gel misplaced, non-vascular.Patient code 1994 captures the reportable event of pain.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.

• 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 Key: 11036606
• MDR Text Key: 222306585
• Report Number: 3005099803-2020-06018
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (y/n): N
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1