MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number M00550601

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a020504 captures the reportable event of tear, rip or hole in the packaging.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was received by the customer on (b)(6) 2023.During unpacking, it was discovered that the device packaging seal was perforated and torn.Also, the corner was crushed.The product was not used in a procedure.There were no patient complications have been reported as a result of this event.

Manufacturer Narrative

Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h2: additional information additional information was received on january 15, 2024 that the damaged packaging was the outer shipping box and not the sterile device packaging.Visibly detectable shipping damage to the device or packaging noted prior to implant would not cause or contribute to a serious injury.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.Block h10: investigation results: the returned packaging of the alliance inflation syringe was analyzed, and a visual examination found that the returned box has its bottom part damaged.Media analysis was performed, the customer provided a picture of the device packaging where it was possible to observe a corner of the box was damaged.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging damaged/defective was confirmed.The results of the analysis performed on the returned device found that the box has its bottom part damaged.These problems could be caused due to environmental factors during the transport or storage of the device, also an incorrect storage of the box, without the proper conditions could have induced the analyzed defects.Therefore, the most probable root cause is cause traced to transport/storage.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was received by the customer on (b)(6) 2023.During unpacking, it was discovered that the device packaging seal was perforated and torn.Also, the corner was crushed.The product was not used in a procedure.There were no patient complications have been reported as a result of this event.Additional information received on january 15, 2024: a photo of the device packaging was provided by the customer and shows that the box of the packaging was damaged and not within the sterile pouch.

• Brand Name: ALLIANCE II
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18452170
• MDR Text Key: 332726440
• Report Number: 3005099803-2023-07008
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922573
• 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,Followup
• Report Date: 02/05/2024

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: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0032433748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• 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