MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number M0068318220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Bowel Perforation (2668)

Event Date 07/12/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an upsylon y mesh kit was implanted into the patient during a procedure performed during a placement of sacrocolpopexy mesh by laparoscopy procedure on (b)(6) 2022.Four days after the mesh was placed, the patient was seen for review for bleeding.Findings showed perforation in the iliac artery and in her colon for which suturing of the iliac and colon as well as mesh removal were performed.The tear in iliac artery was controlled but it bled again.The doctors noted that the patient has an unusual transposition of a vein close to the iliac artery.The patient was hospitalized but her condition has reportedly improved.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block b5 has been updated with the patient's current condition based on the additional information received on november 8, 2022.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: patient codes e1006, e0511 and e0506 capture the reportable events of colon perforation, iliac artery perforation and bleeding.Impact codes f1901, f1903 and f08 capture the reportable events of suturing of perforation, mesh removal and hospitalization.

Event Description

It was reported to boston scientific corporation that an upsylon y mesh kit was implanted into the patient during a procedure performed during a placement of sacrocolpopexy mesh by laparoscopy procedure on (b)(6) 2022.Four days after the mesh was placed, the patient was seen for review for bleeding.Findings showed perforation in the iliac artery and in her colon for which suturing of the iliac and colon as well as mesh removal were performed.The tear in iliac artery was controlled but it bled again.The doctors noted that the patient has an unusual transposition of a vein close to the iliac artery.The patient was hospitalized but her condition has reportedly improved.The patient is doing very well at home.

• Brand Name: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15180585
• MDR Text Key: 297411033
• Report Number: 3005099803-2022-04358
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female