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MAUDE MDR 1352681

MDR report key
1352681
Report number
1352681
Event key
0
Event type
3
Date of event
2008-11-25
Date received
2008-12-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PILLING /WECK/ TELEFLEXBRONCHIAL DILATORTELEFLEX MEDICALKCG* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-12-0901. D

Event Narratives#

D

Patient 1

THIS PATIENT WAS BROUGHT TO THE OR FOR RIGID BRONCHOSCOPY AND TRACHEAL DILATATION. DURING THE PROCEDURE, THE TIP OF THE DILATOR (#22 PILLING) AND THE BODY OF THE DILATOR BECAME SEPARATED. THE TIP LODGED IN THE RIGHT MAIN STEM BRONCHUS. THE PATIENT'S SAO2 AND HEART RATE IMMEDIATELY DROPPED; CPR WAS INITIATED, ET TUBE WAS INSERTED. AFTER THE PATIENT WAS SUCCESSFULLY RESUSCITATED, THE ET TUBE WAS REMOVED AND DILATATION CONTINUED. AFTER THE PROCEDURE, THE PATIENT WAS RETURNED TO THE ICU WHERE HE REMAINED UNRESPONSIVE TO ORAL OR PAIN STIMULI. DEVICE EVALUATED BY MFR: NOT RETURNED TO MFR. THE SET OF DILATORS WAS IMMEDIATELY PULLED FROM SERVICE.