MAUDE Adverse Event Report: GREATBATCH MEDICAL MOBICATH STEERABLE SHEATH

Model Number 1000182-001

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was observed that there was blood flowback from the valve of the mobicath sheath when a catheter was inserted.The catheter was removed and it was found that the valve was inside and not closed completely.The issue was resolved by changing the sheath to another one.The procedure was completed without patient consequence.

Manufacturer Narrative

Na.

• Brand Name: MOBICATH STEERABLE SHEATH
• Type of Device: STEERABLE SHEATH
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane north; minneapolis MN 55441
• Manufacturer Contact: kristi fox, senior specialist ; 2300 berkshire lane north; minneapolis, MN 55441 ; 7639518181
• MDR Report Key: 4113651
• MDR Text Key: 4920559
• Report Number: 2183787-2014-00109
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2015
• Device Model Number: 1000182-001
• Device Lot Number: W2704003
• Other Device ID Number: D-1400-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other