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

Model Number M00566670

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Section e: this event was reported by the sales representative.The health care facility is: (b)(6) hospital (b)(6) block h6: imdrf device code a020503 captures the reportable event of seal compromised.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was being prepared for use in a procedure on (b)(6) 2023.During preparation, it was noticed that there were wrinkles at the product opening.No patient complications were reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17313212
• MDR Text Key: 319499327
• Report Number: 3005099803-2023-03730
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial
• Report Date: 07/12/2023

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: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0031313833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1