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

Model Number M00513740

Device Problem Positioning Problem (3009)

Patient Problems Dyspnea (1816); Choking (2464)

Event Date 11/09/2016

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) 2016 that an ultraflex esophageal distal release stent was to be used to treat a 7 cm malignant stricture in the upper or mid esophagus which is approximately 4 cm away from the cricopharynx during an upper gi series (ugi) procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was tortuous and was dilated using a bougie dilator prior to stent placement procedure.According to the complainant, during the procedure, the physician had difficulty crossing the stent through the lesion.During deployment, the catheter bowed and the physician experienced difficulty in deploying the stent.The stent was deployed proximal to the cricopharynx.Reportedly, the patient experienced breathing problems and was choking.The physician removed the stent using forceps and completed the procedure with another ultraflex esophageal stent using a stiff guidewire.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on november 10, 2016 that an ultraflex esophageal distal release stent was to be used to treat a 7 cm malignant stricture in the upper or mid esophagus which is approximately 4 cm away from the cricopharynx during an upper gi series (ugi) procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was tortuous and was dilated using a bougie dilator prior to stent placement procedure.According to the complainant, during the procedure, the physician had difficulty crossing the stent through the lesion.During deployment, the catheter bowed and the physician experienced difficulty in deploying the stent.The stent was deployed proximal to the cricopharynx.Reportedly, the patient experienced breathing problems and was choking.The physician removed the stent using forceps and completed the procedure with another ultraflex esophageal stent using a stiff guidewire.There were no other 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 ng stent and delivery system were received for analysis.Visual examination of the returned device found the shaft was curved.One wire loop on the distal end was broken.In addition, the retention suture on the distal end of the stent appeared to be tangled.However, the suture was able to be manipulated back into the correct position.No other issues were identified during the product analysis.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on november 10, 2016 that an ultraflex esophageal distal release stent was to be used to treat a 7 cm malignant stricture in the upper or mid esophagus which is approximately 4 cm away from the cricopharynx during an upper gi series (ugi) procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was tortuous and was dilated using a bougie dilator prior to stent placement procedure.According to the complainant, during the procedure, the physician had difficulty crossing the stent through the lesion.During deployment, the catheter bowed and the physician experienced difficulty in deploying the stent.The stent was deployed proximal to the cricopharynx.Reportedly, the patient experienced breathing problems and was choking.The physician removed the stent using forceps and completed the procedure with another ultraflex esophageal stent using a stiff guidewire.There were no other 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: 6136330
• MDR Text Key: 61162478
• Report Number: 3005099803-2016-03726
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167(17)20180414(10)19143919
• 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,Followup
• Report Date: 11/10/2016

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: 04/14/2018
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 19143919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2016; 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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: 68 YR
• Patient Weight: 56