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

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problem Dysuria (2684)

Event Date 12/04/2020

Event Type  malfunction  

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.Additionally, the procedure was done under general anesthesia.According to the complainant, during injection, the physician had some resistance in pushing the kit.Unknowingly the physician had advanced the needle very far back into the patient and injected 2cc of spaceoar in the bladder.The patient had urinated out some of the spaceoar gel.The patient did not have urinary retention but the doctor put a catheter in over the weekend just in case.Reportedly, the physician took out the catheter, and checked the patient's bladder and it was fine.The patient had a fever and was given antibiotics.The physician concluded that the fever was not related to the spaceoar.The patient also had a mild dysuria and will receive external beam radiation therapy (ebrt).

• 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: 11072119
• MDR Text Key: 223604119
• Report Number: 3005099803-2020-06290
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/24/2020
• 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