MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513750

Device Problems Device Markings/Labelling Problem (2911); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; 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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used treat a 10-cm malignant stricture in the esophagus during a stenting procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during fluoroscopic stent deployment, the stent began to release from the proximal end of the delivery catheter, and then the stent was deployed in an incorrect location.Reportedly, the complainant confirmed that the device packaging label indicates a distal release stent (and not a proximal release stent).The stent was removed with forceps and the procedure was completed with another ultraflex esophageal stent.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

A deployed ultraflex esophageal covered stent was received for analysis; the box and the delivery system were not returned.The stent was received expanded.Visual examination identified no damage or issue with the stent.The green retention suture was inspected and no anomalies were noted in both ends.The investigation concluded that the reported event was likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probably root cause is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used treat a 10-cm malignant stricture in the esophagus during a stenting procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during fluoroscopic stent deployment, the stent began to release from the proximal end of the delivery catheter, and then the stent was deployed in an incorrect location.Reportedly, the complainant confirmed that the device packaging label indicates a distal release stent (and not a proximal release stent).The stent was removed with forceps and the procedure was completed with another ultraflex esophageal stent.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.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7603466
• MDR Text Key: 111136845
• Report Number: 3005099803-2018-01934
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• 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: 05/22/2018

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: 10/21/2019
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 21285057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2017
• 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: 47 YR