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

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problems Nausea (1970); Pain (1994); Discomfort (2330)

Event Date 06/08/2021

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 was disposed 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 medwatch 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) 2021.During the procedure, the physician took a couple of tries to find the correct plane in the perirectal fat.The hydrodissection was in the correct plane upon final check.The first 7 ccs of spaceoar gel were applied easily, the last 3 ccs required a lot more pressure.It is possible that the gel was misplaced into tissue.The patient made no mention of discomfort until the transrectal ultrasound guided (trus) probe was removed.The patient then complained of intense rectal pain and became nauseous.The patient went to the bathroom to void his bladder and bowels.The patient was brought to the emergency room (er) with intense pain in his rectal area.The pain was too severe for the physician to spread open the patient's buttocks area to do a rectal exam.The patient received a computerized tomography scan.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2021.During the procedure, the physician took a couple of tries to find the correct plane in the perirectal fat.The hydrodissection was in the correct plane upon final check.The first 7 ccs of spaceoar gel were applied easily, the last 3 ccs required a lot more pressure.It is possible that the gel was misplaced into tissue.The patient made no mention of discomfort until the transrectal ultrasound guided (trus) probe was removed.The patient then complained of intense rectal pain and became nauseous.The patient went to the bathroom to void his bladder and bowels.The patient was brought to the emergency room (er) with intense pain in his rectal area.The pain was too severe for the physician to spread open the patient's buttocks area to do a rectal exam.The patient received a computerized tomography scan.On july 6, 2021, additional information was received stating that the procedure was done under local anesthesia and the patient was treated with course of antibiotics to stop any infection.The patient condition has returned to normal life and is waiting for a rectal scope to determine if he will move forward with radiation.

Manufacturer Narrative

Block b5: additional information received on 6jul2021.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: clinical code e2330 captures the reportable event of pain.Medical device problem code a1502 captures the reportable event of gel misplaced, non-vascular.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 was disposed 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 medwatch will be filed.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12122045
• MDR Text Key: 260057879
• Report Number: 3005099803-2021-03241
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR