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 Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) captures the reportable event of labeling problem.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 ii system - halo package was received and unpacked on (b)(6) 2018.This device was about to be used in a procedure.According to the complainant, during unpacking the obtryx ii system - halo package, it was noticed that the inside sterile package was labeled for an obtryx ii system curved device.The packaging was completely intact and was not used on a patient.The procedure was completed with another obtryx ii system - halo device.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo package was received and unpacked on august 28, 2018.This device was about to be used in a procedure.According to the complainant, during unpacking the obtryx ii system - halo package, it was noticed that the inside sterile package was labeled for an obtryx ii system curved device.The packaging was completely intact and was not used on a patient.The procedure was completed with another obtryx ii system - halo deivce.Additional information received on september 28, 2018.The needles inside the package were curved.

Manufacturer Narrative

Problem code 2911 captures the reportable event of labeling problem.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 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: 7904766
• MDR Text Key: 121563990
• Report Number: 3005099803-2018-60584
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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: 05/30/2021
• Device Model Number: M0068505110
• Device Catalogue Number: 73207
• Device Lot Number: 0022189631
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1