MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CONTOUR PVA MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Model Number M0017600250

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

It was reported that during preparation for an embolic treatment procedure, the particles were not the correct size.Upon opening of a second vial of contour pva microspheres the physician noted that the size of the particles were different than the previous vial, particle size was not consistent and looked ¿lumpy.¿ the procedure was completed with another of the same product.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by manufacturer - 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.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer - the particle sizes of the returned contour particles were measured and were found to be within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is ¿user preference issue¿ as the user is dissatisfied with the function or performance of the product.(b)(4).

Event Description

It was reported that during preparation for an embolic treatment procedure, the particles were not the correct size.Upon opening of a second vial of contour pva microspheres the physician noted that the size of the particles were different than the previous vial, particle size was not consistent and looked ¿lumpy.¿ the procedure was completed with another of the same product.No patient complications were reported and the patient's status is stable.

• Brand Name: CONTOUR PVA MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3792728
• MDR Text Key: 4528067
• Report Number: 2134265-2014-02659
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K030966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: M0017600250
• Device Catalogue Number: 760025S
• Device Lot Number: 15995409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• 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
• Patient Age: 51 YR