MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505000

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

Patient Problems Nerve Damage (1979); Pain (1994); Injury (2348); No Code Available (3191); Insufficient Information (4580)

Event Date 08/17/2010

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to 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 an obtryx halo single system device was implanted during a vaginal sacrocolpopexy, reverse obtryx tape, sphincteroplasty, and hormone implant procedure performed on (b)(6) 2010 to treat enterocele.As reported by the patient's attorney, the patient has experienced an unspecified injury with the obtryx halo single system device.On (b)(6) 2010, the patient underwent removal of the right and left sutures from pararectal space.She also had a left sacroplasty procedure and was also implanted with a non-bsc device for neuralgic pain from the suture on the left sacrospinous ligament.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system device was implanted during a vaginal sacrocolpopexy, reverse obtryx tape, sphincteroplasty, and hormone implant procedure performed on (b)(6) 2010 to treat enterocele.As reported by the patient's attorney, the patient has experienced an unspecified injury with the obtryx halo single system device.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Correction to blocks b5, b7 and h6: the events of nerve damage, pain and surgery were moved to patient's history since these were attributed to the non-bsc device/procedure.Block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2401 captures the reportable event of unspecified injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to 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: OBTRYX SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11138973
• MDR Text Key: 225742462
• Report Number: 3005099803-2021-00014
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML0030204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR