MAUDE Adverse Event Report: RICE CREEK MFG ATTAIN; CATHETER, FLOW DIRECTED

Model Number 6215

Device Problem Use of Device Problem (1670)

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

Event Date 09/25/2013

Event Type  malfunction  

Event Description

It was reported that after doing the venogram the balloon was not deflatable.The physician tried several times to deflate it with the syringe however, the balloon was still visible in the x-ray as inflated.The physician decided to strongly retract the balloon into the catheter.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary- analysis was performed and no anomalies were found.(b)(4).

• Brand Name: ATTAIN
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): RICE CREEK MFG; 700 central ave n.e.; fridley MN 55432
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3619653
• MDR Text Key: 4133521
• Report Number: 2182208-2014-00533
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K012225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2015
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 61301083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2013
• Date Manufacturer Received: 09/25/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1