MAUDE Adverse Event Report: STERILMED, INC.; REPROCESSED INTRAVASCULAR ULTRASOUND

Model Number BIOSNDSTR10

Device Problem Poor gas exchange (1464)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that the device had a defective steering mechanism.The device was replaced and the procedure was continued and subsequently completed.Ther were no patient consequences.This report is being filed for the findings upon investigation.It was later reported that the issue ws discovered almost immediately during mapping.No breach in the device insulation was noticed during the procedure.The device was placed on the back table after being replaced.

Manufacturer Narrative

Final device investigation found that the device was returned with a portion of the outer coating torn/worn/scratched away exposing the wire braiding and creating rough surfaces.The device was coiled and had several kinks in the length of the shaft.Upon evaluation, the device did not pass the straightness (centerline) test, which was possibly due to the manner in which the device was returned.The mobility of the device was also affected; the device did not fully deflect as intended.The device was electrically tested and failed the acoustic verification/calibration test, but passed all other electrical testing including hi-pot, signal strength and ultrasound testing.The damage to the outer coating of the shaft was possibly due to the device being packaged for return without being adequately secured causing excess friction during return shipping.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Type of Device: REPROCESSED INTRAVASCULAR ULTRASOUND
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4188050
• MDR Text Key: 15124950
• Report Number: 2134070-2014-00181
• Device Sequence Number: 1
• Product Code: OWQ
• Combination Product (y/n): N
• PMA/PMN Number: K110076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: BIOSNDSTR10
• Device Catalogue Number: SNDSTR10
• Device Lot Number: 1704304
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1