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

Model Number 3040

Device Problem Contamination (1120)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that a hair was present on the pressure pump gauge.A encore 26 inflation device was selected for use.Upon unpacking, it was noted that there was a hair attached to the pressure pump gauge.The device was considered contaminated and the procedure was completed with another of the same device.No complications were reported and the patient was stable.

Event Description

It was reported that a hair was present on the pressure pump gauge.A encore 26 inflation device was selected for use.Upon unpacking, it was noted that there was a hair attached to the pressure pump gauge.The device was considered contaminated and the procedure was completed with another of the same device.No complications were reported and the patient was stable.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the gauge needle was at 0 atm when received.The device did not have visual defects or any contamination.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17399142
• MDR Text Key: 319843952
• Report Number: 2124215-2023-39363
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0030564322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 67 KG