MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068318250

Device Problems Use of Device Problem (1670); Misfire (2532); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf device code a050502 captures the reportable event of device misfire.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous ligament fixation procedure in the vagina, performed on (b)(6) 2023.During the procedure, the device misfired and the suture needle was not caught in the cage.There have been multiple attempts to reload the suture and refire.Another capio slim device was opened and successfully completed the procedure.The patient had experienced bleeding and hematoma during the procedure and may have a developing abscess.A surgiflo was used to control the bleeding secondary to the misfires.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous ligament fixation procedure in the vagina, performed on (b)(6) 2023.During the procedure, the device misfired and the suture needle was not caught in the cage.There have been multiple attempts to reload the suture and refire.Another capio slim device was opened and successfully completed the procedure.The patient had experienced bleeding and hematoma during the procedure and may have a developing abscess.A surgiflo was used to control the bleeding secondary to the misfires.

Manufacturer Narrative

Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf device code a050502 captures the reportable event of device misfire.Block h10: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual analysis did not identify any damages to the returned device; however, it was noted that the carrier was not fully retracted.The carrier was able to move in and out after deploying and the cage was able to catch the suture.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of failure to catch needle was not confirmed.The impact code additional device required was caused due to the complaint events reported, the hemorrhage, hematoma and abscess reported were also known and noted in the labeling.Furthermore, it was confirmed through analysis that the device carrier was not fully retracting into the head; further investigation is in progress to address this observation.A conclusion code of cause traced to device design was assigned to this investigation.Block h11: block h6 device code has been corrected.

Manufacturer Narrative

Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf device code a050502 captures the reportable event of device misfire.Block h10: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual analysis did not identify any damages to the returned device; however, it was noted that the carrier was not fully retracted.The carrier was able to move in and out after deploying and the cage was able to catch the suture.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of failure to catch needle was not confirmed.The impact code additional device required was caused due to the complaint events reported, the hemorrhage, hematoma and abscess reported were also known and noted in the labeling.Furthermore, it was confirmed through analysis that the device carrier was not fully retracting into the head; further investigation is in progress to address this observation.A conclusion code of cause traced to device design was assigned to this investigation.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous ligament fixation procedure in the vagina, performed on (b)(6) 2023.During the procedure, the device misfired and the suture needle was not caught in the cage.There have been multiple attempts to reload the suture and refire.Another capio slim device was opened and successfully completed the procedure.The patient had experienced bleeding and hematoma during the procedure and may have a developing abscess.A surgiflo was used to control the bleeding secondary to the misfires.

• Brand Name: CAPIO SLIM
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18460446
• MDR Text Key: 332253365
• Report Number: 2124215-2023-73837
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729838005
• UDI-Public: 08714729838005
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318250
• Device Catalogue Number: 831-825
• Device Lot Number: 0030993213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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): Required Intervention
• Patient Sex: Female