MAUDE Adverse Event Report: SORIN GROUP USA, INC. BIOSENSORS EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Catalog Number 3EMB80

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2014

Event Type  Other  

Event Description

Sorin group rec'd a report that the balloon of the embolectomy catheter broke during the procedure.All of the pieces of the balloon were recovered from the pt.There was no report of pt injury.

Manufacturer Narrative

The investigation is ongoing.A f/u report will be sent when the investigation is complete.

• Brand Name: BIOSENSORS EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: cheri voorhees, manager ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3733316
• MDR Text Key: 4271304
• Report Number: 1718850-2014-00073
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3EMB80
• Device Lot Number: 100200379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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