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

Model Number 25335

Device Problem Material Integrity Problem (2978)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The event date of 01jul2023 is an estimated based of the aware date of (b)(6) 2023 as the exact date was not reported.Device evaluated by mfr: the device was returned for evaluation.The gauge needle was at 0 atm when received.The device has a drop of water inside the tube and a foreign material was found inside the pouch.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that there is a drop of water inside the tube.The target lesion was in the shunt limb.An encore 26 inflation device was selected for used.During preparation, it was noted that there is a drop of water inside the tube.The procedure was completed with another of the same device.There is no patient injury.However, device investigations revealed that a foreign material was found inside the pouch.

• 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: 18141633
• MDR Text Key: 328504321
• Report Number: 2124215-2023-62430
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/15/2023

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: Health Professional
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0031199609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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