MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564710

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex¿ tracheobronchial distal release covered stent was used in the lungs during an airway stenting procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the physician attempted to deploy the stent; however, it failed to deploy completely.The partially deployed stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Reported event of stent failed to expand.A fully-deployed ultraflex tracheobronchial delivery system was returned for analysis.An ultraflex tracheobronchial stent was also returned.A visual examination noted that the returned delivery system matches with the reported lot number; however, the returned stent does not match with the reported lot number.The reported stent size was 14 mm x 40 mm, but the received stent measures 12 mmx 20 mm.The received stent was noted to be fully expanded.Additionally, the device shaft was kinked and indentations at the distal end of the shaft were noted.No other issues were identified during the product analysis.Attempts to obtain clarification of the discrepancy with the returned device have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(4) 2016 that an ultraflex¿ tracheobronchial distal release covered stent was used in the lungs during an airway stenting procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the physician attempted to deploy the stent; however, it failed to deploy completely.The partially deployed stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 13, 2017: the complainant reported that the stent was fully deployed inside the patient, but failed to expand to its proper size.Additional information received on january 20, 2017: it was reported that the physician removed the stent from the patient using forceps.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6195983
• MDR Text Key: 63069811
• Report Number: 3005099803-2016-03883
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2018
• Device Model Number: M00564710
• Device Catalogue Number: 6471
• Device Lot Number: 18942124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 55