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

Model Number M0068505110

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system-halo device was received and unpacked during a stress urinary incontinence treatment procedure on (b)(6) 2020.According to the complainant, after unpacking, a strand of hair was observed inside the sterile box of the device.There was no visible damage noted on the package or the device itself.The procedure was completed with another obtryx ii system-halo device.There were no patient complications as a result of the event as the device was not used on the patient.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an obtryx ii system-halo device was received and unpacked during a stress urinary incontinence treatment procedure on (b)(6), 2020.According to the complainant, after unpacking, a strand of hair was observed inside the sterile box of the device.There was no visible damage noted on the package or the device itself.The procedure was completed with another obtryx ii system-halo device.There were no patient complications as a result of the event as the device was not used on the patient.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: device code 1120 captures the reportable event of hair inside the sterile box.Block h10: a visual examination of the returned obtryx ii system - halo revealed that a hair was found inside of a sterile box, confirming the reported complaint.Based on the investigation conducted, the investigation concluded that the most probable cause for this complaint is manufacturing deficiency which indicates problems traced to manufacturing process.An investigation was opened to address the issue of "a hair was found inside of a sterile box." it was determined that no further containment is required as this was an isolated event.

• Brand Name: OBTRYX II 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: 10460056
• MDR Text Key: 204567731
• Report Number: 3005099803-2020-03555
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• PMA/PMN Number: K121754
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0025060319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1