MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Catheter, Septostomy

Model Number	VXSK0132
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before procedure, a versacross access solution was selected for use.When the product box was received from shipment, it was extremely damaged, there were holes in the box and the sterile pouch was punctured, rendering the product unsterile.Procedure was performed by using a product backup, there were no patient complications.The product will not be returned for evaluation as it was disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that before procedure, a versacross access solution was selected for use.When the product box was received from shipment, it was extremely damaged, there were holes in the box and the sterile pouch was punctured, rendering the product unsterile.Procedure was performed by using a product backup, there were no patient complications.The product will not be returned for evaluation as it was disposed.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event of not sterile and tear, rip or hole in device packaging was confirmed by media provided.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review performed for the versacross device confirmed that the event of not sterile and tear, rip or hole in device packaging are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Investigation conclusion: boston scientific has assigned an investigation conclusion code of cause traced to transport/storage and supporting evidence that came to this conclusion.The device has not been returned to bsc for analysis, although media provided confirms the allegation.The root cause cannot be determined with certainty based on the information available, however it is likely that the damage occurred during shipping/transport.Sterilization record review was also conducted, and no issues were identified regarding the sterilization process.Due to these factors, it was determined that the sterile barrier breach was not a result of a bsc manufacturing or packaging/handling process but rather the result of shipping damage that occurred outside of bsc control and was easily identifiable prior to use in a patient.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• Brand Name: VersaCross Access Solution
• Common Device Name: Catheter, Septostomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25728068
• Report Number: 2124215-2026-36139
• Device Sequence Number: 10252743
• Product Code: DXF
• UDI-Device Identifier: 00685447019879
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: VXSK0132
• Device Catalogue Number: VXSK0132
• Device Lot Number: 0038922911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown