MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE¿ 26; SYRINGE, BALLOON INFLATION

Model Number M001151050

Device Problems Material Separation (1562); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

Encore 26 inflation device being used during case appears to have a defect in the plastic.Small round area was noticed after using device.Was not sure if part of plastic came off inside the syringe/tubing part of the device.

• Brand Name: ENCORE¿ 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17208338
• MDR Text Key: 317935253
• Report Number: 17208338
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)241212(10)30702281
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M001151050
• Device Lot Number: 30702281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 105 KG