MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

Model Number M0068402410

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a polyform synthetic mesh was about to be used in a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, the mesh was found out to be stuck in the seal of the sterile pouch.The device was not used in the patient.The procedure was completed with another of the same polyform mesh.There were no patient consequences are reported.

Manufacturer Narrative

A visual examination of the returned polyform synthetic mesh revealed that the inner pouch was returned opened.Witness marks along the bottom of the pouch confirmed that the mesh was caught in the seal.The pouch was not sealed where the mesh was caught in the seal.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is supplier manufacturing execution error as the design or validation of a suppliers manufacturing process was not executed as validated.The issue is under investigation.

Event Description

It was reported to boston scientific corporation that a polyform synthetic mesh was about to be used in a procedure performed on (b)(6) 2018.According to the complainant, during unpacking, the mesh was found out to be stuck in the seal of the sterile pouch.The device was not used in the patient.The procedure was completed with another of the same polyform mesh.There were no patient consequences are reported.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7578556
• MDR Text Key: 110377328
• Report Number: 3005099803-2018-01706
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: M0068402410
• Device Catalogue Number: 840-241
• Device Lot Number: C003602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1