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

Model Number M0068505000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device is contaminated and 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 system - halo device was used during a urinary incontinence treatment with mesh placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the mesh was torn into pieces at the time of adjustment in the middle urethra.The procedure was complete with another obtryx system - halo device.There were no patient complications as a result of the event.

Manufacturer Narrative

Additional information: blocks b1, b2, b5, e1: initial reporter phone, h1, and h10 (below) have been updated based on the additional information received from the customer.Block e1: physician's complete name: (b)(6).Block h6: device code 4008 captures the reportable event of mesh torn.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is contaminated and discarded and 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 system - halo device was used during a urinary incontinence treatment with mesh placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the mesh was torn into pieces at the time of adjustment in the middle urethra.The procedure was complete with another obtryx system - halo device.There were no patient complications as a result of the event.It was reported that there was no complete separation of the mesh and the entire mesh was completely removed from the patient by hand.The condition of the patient after the procedure was reportedly good.

• 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: 10511234
• MDR Text Key: 206511550
• Report Number: 3005099803-2020-03692
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0024479057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR