MAUDE Adverse Event Report: CONTRACT MEDICAL INTL. GMBH EZ - BLOCKER ENDOBRONCHIAL BLOCKER

Catalog Number MG-02770-002

Device Problems Bent (1059); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges the device was placed to isolate the right lung and ventilate the left lung.The pt was turned and the cuff was inflated.The anesthesiologist re-inserted the bronchoscope to visualize the cuff and noticed that it was bent upwards away from the right lung facing the upper airway.The doctor pulled back the device and rotated it to place the cuff.No pt injury or harm.

Manufacturer Narrative

The complaint device won't be returned for an eval.Lot number of the device was not reported.The investigation of the root cause was not completed at the time of this report because more detailed info has not been provided yet.Each endobronchial blocker is being checked by cmi during final 100% leak testing.Cmi operators check for correct outer diameter and correct shape of inflated balloons i s compared to picture attachment.In this attachment is picture which shows still acceptable bending.Estimated date of follow up report is (b)(6) 2014.

• Brand Name: EZ - BLOCKER ENDOBRONCHIAL BLOCKER
• Type of Device: ENDOBRONCHIAL BLOCKER
• Manufacturer (Section D): CONTRACT MEDICAL INTL. GMBH; lauensteiner str 37; dresden 0127 7; GM 01277
• Manufacturer Contact: jan kloboucnik, ra/qa dir ; lauensteiner str 37; dresden 01277 ; GM 01277 ; 494949564
• MDR Report Key: 4309216
• MDR Text Key: 21244092
• Report Number: 3003637635-2014-00002
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MG-02770-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• 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