MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELECTRA MPH-45; CATHETER

Model Number 375533

Device Problem Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This selectra was used during a case on (b)(6) 2017.During the case when the physician was slitting/removing the sheath, about 3 inches or so was left in the patient.The physician called in two different cardiac surgeons who agreed that it was better to leave the 3 inches of sheath inside the patient instead of trying to remove it.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: SELECTRA MPH-45
• Type of Device: CATHETER
• 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: 6824833
• MDR Text Key: 83803377
• Report Number: 1028232-2017-02984
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 375533
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05167509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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): Other
• Patient Age: 84 YR