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

Model Number	M0068318220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Bowel Perforation (2668)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005099803-2022-04358
• Device Sequence Number: 6330128
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 08/06/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female