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

Model Number M0068318261

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a sacrospinous ligament fixation procedure performed on (b)(4) 2022.During the procedure, the physician experienced difficulty with "anchoring" and was concerned that it was unsafe as it is a blind access approach when the device is being deployed.The patient bled, and more floseals and more sutures were used to reinforce /redo stitches that gave up every failed attempt at anchoring.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block g2: the voluntary user medwatch number is 3800750000-2022-8009.Block h6: imdrf device code a0501 captures the reportable event of suture breakage.

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a sacrospinous ligament fixation procedure performed on (b)(6), 2022.During the procedure, the physician experienced difficulty with "anchoring" and was concerned that it was unsafe as it is a blind access approach when the device is being deployed.The patient bled, and more floseals and more sutures were used to reinforce /redo stitches that gave up every failed attempt at anchoring.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Correction to blocks b1, b2, h1, and h6 (below).Block g2: the voluntary user medwatch number is (b)(4).Block h6: imdrf device code a0501 captures the reportable event of suture breakage.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f2301 captures the reportable event of using floseals to treat the bleeding.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16929976
• MDR Text Key: 315194773
• Report Number: 3005099803-2023-02592
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0030254839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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 Age: 55 YR
• Patient Sex: Female