MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH COLPASSIST¿; MESH, SURGICAL, SYNTHETIC

Model Number M0068318210

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a colpassist¿ was to be used during a mid-urethral sling procedure performed on (b)(6) 2017.According to the complainant, during preparation, there was a black foreign matter with the device inside the package.The device was not used on a patient.The procedure was completed with another colpassist¿.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A visual examination of the returned colpassist vaginal positioning device revealed that there is a black foreign matter inside the sealed package.A review of the device history record (dhr) confirmed that the device was manufactured in accordance with device master record.The investigation concluded that the root cause is supplier manufacture as this complaint is associated with a product that fails to meet specification due to the manufacturing process at a supplier site.There is an investigation in place to address this issue.

Event Description

It was reported to boston scientific corporation that a colpassist¿ was to be used during a mid-urethral sling procedure performed on (b)(6) 2017.According to the complainant, during preparation, there was a black foreign matter with the device inside the package.The device was not used on a patient.The procedure was completed with another colpassist¿.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: COLPASSIST¿
• Type of Device: MESH, SURGICAL, SYNTHETIC
• 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: 6639251
• MDR Text Key: 77518939
• Report Number: 3005099803-2017-01746
• Device Sequence Number: 1
• Product Code: KOH
• UDI-Device Identifier: 08714729848097
• UDI-Public: (01)08714729848097(17)20200331(10)C003369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: M0068318210
• Device Catalogue Number: 831-821
• Device Lot Number: C003369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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