MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELECTRA BIO2-45; INTRODUCER SYSTEM, GUIDE WIRE

Model Number 375523

Device Problems Difficult to Remove (1528); Material Perforation (2205)

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

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Until today, the medical device is not available for analysis and could not be examined.The information and diagnostic imaging that you made available have been analyzed in depth.The available x-ray images show a probably intracardially located tvi (transvalvular insertion tool) and an additional medical device, which could be the snare kit, which was mentioned in the complaint.Despite the available information no final assessment can be made, since an analysis of the tvi would be necessary.If at any time, additional relevant information or the device itself becomes available, we ask you to send it.Then the report will be updated accordingly.

Event Description

Ous mdr - during a crt implantation a guide wire from the selectra accessory kit was suddenly missing.At the time the tip of the selectra bio2-45 was in the right ventricle of the patient.During fluoroscopy it was found that the guide wire was stuck partly in selectra and the rest was found in the ventricle.The guide wire was carefully retracted and, at first, it was coming out just fine, but then it got stuck around the clavicle.Using a snare kit, the guide wire was successfully recovered.The device was not returned.

• Brand Name: SELECTRA BIO2-45
• Type of Device: INTRODUCER SYSTEM, GUIDE WIRE
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 5818888
• MDR Text Key: 50320792
• Report Number: 1028232-2016-02544
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 375523
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2015
• 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): Hospitalization