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 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.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 used during a tension-free vaginal mesh (tvm) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, about 5 mm of the mesh was found to be sealed at the bottom part of the sterilization pouch.That part was cut along with the pattern and the rest of the mesh was implanted.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Analysis revealed that the returned package shows evidence that the mesh was caught partway in the bottom seam of the pouch.The seal of the package was compromised but not breached.The mesh was not returned.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot. since the condition of the returned device confirms that the seal was compromised, the assigned complaint investigation conclusion code for this event is supplier manufacturing execution error.A suppliers manufacturing process was not executed as validated.There is an investigation in place to address this issue.

Event Description

It was reported to boston scientific corporation that a polyform synthetic mesh was used during a tension-free vaginal mesh (tvm) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, about 5 mm of the mesh was found to be sealed at the bottom part of the sterilization pouch.That part was cut along with the pattern and the rest of the mesh was implanted.There were no patient complications reported as a result of this event.

• 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: 7140896
• MDR Text Key: 95827017
• Report Number: 3005099803-2017-03840
• 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: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: M0068402410
• Device Catalogue Number: 840-241
• Device Lot Number: C003478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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