MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK FLOSWITCH? HP; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001442001

Device Problem Mechanical Problem (1384)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported that user injury occurred.During a uterine fibroid embolization procedure using a floswitch¿ hp, the physician noted that the device was ¿sticky¿ and difficult to open and close.During use the physician¿s glove was ripped and had a finger laceration, the physician came into contact with the patient¿s blood.The patient tested negative for any blood borne pathogens.No additional patient or user complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer - it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: FLOSWITCH? HP
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4770813
• MDR Text Key: 18092529
• Report Number: 2134265-2015-03171
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: M001442001
• Device Catalogue Number: 44-200
• Device Lot Number: 17552944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• 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 Outcome(s): Other