FDA Adverse Event Injury Summary report: N

ULTRAFLEX? TRACHEOBRONCHIAL

MDR report key: 4863541 · Received June 23, 2015

Report

Report Number: 3005099803-2015-01731
Event Type: Injury
Date Received: June 23, 2015
Report Date: May 28, 2015
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: JCT
PMA / PMN Number: K012883
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX¿ TRACHEOBRONCHIAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE, THE ULTRAFLEX¿ TRACHEOBRONCHIAL STENT WAS FULLY DEPLOYED FROM THE DELIVERY SYSTEM. IMMEDIATELY FOLLOWING THE STENT PLACEMENT, THE PHYSICIAN NOTED THAT THE STENT HAD NOT FULLY EXPANDED. THE ULTRAFLEX¿ TRACHEOBRONCHIAL STENT WAS REMOVED FROM THE PATIENT USING A RIGID SCOPE WITH FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
405116	ULTRAFLEX? TRACHEOBRONCHIAL	PROSTHESIS, TRACHEAL, EXPANDABLE	JCT	BOSTON SCIENTIFIC - GALWAY	UNK449

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention