MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513740

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on august 12, 2020, that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant esophageal tumor during an esophageal stenting procedure performed on (b)(6) 2020.According to the complainant, during preparation, when the device was unpacked, it was noted that the tip was damaged.The stent was not introduced into the patient.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.

Event Description

It was reported to boston scientific corporation on august 12, 2020 that an ultraflex esophageal distal covered stent was to be used to treat an esophageal malignant tumor during a stenting procedure performed on (b)(6) 2020.According to the complainant, during preparation, when the device was unpacked, it was noted that the tip was damaged.The stent was not introduced into the patient.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

Block e1: initial reporter's health care facility: the (b)(6) hospital (b)(6).Block h6: device problem code 2978 captures the reportable event of tip damaged/defective.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was returned fully covered by the deployment suture and undeployed.Visual examination of the returned device did not find any damages to the stent and delivery system.The reported event of tip damaged/defective was not confirmed; the tip of the delivery system was inspected and no damages were noted.Taking all available information, there is no indication of what the customer reported because the device was inspected and no anomalies were noted.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10478390
• MDR Text Key: 224310893
• Report Number: 3005099803-2020-03664
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0022496159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60