MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-17 XSUPPORT; CATHETER, PERCUTANEOUS

Model Number	MC172150SX
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: after opening the outer packaging of the product, it was found that the inner packaging was not completely sealed.After replacing with another product of the same specification, procedure was performed.After comparing with other products of the same specifications, it was found that the sealing marks on the two ends of the package were relatively shallow.Patient status is normal.
Additional Manufacturer Narrative
Items returned for investigation: headway 17 microcatheter; dispenser hoop; product pouch.The pouch was returned unsealed at both top and bottom edges, which is consistent observed in the customer provided images.Comparison of the bottom edge seal with an in-house unit showed that the returned unit was more transparent, indicating a weaker heat bond than the in-house unit.The texture of the seal indicates that the pouch did undergo sealing and had a partial heat seal.Per specifications, it is to be verified that the pouch seal is without gaps, voids, non-homogeneous or undersealed areas, over sealed areas, cracks and/or pinholes along the seal, contamination, in-house narrow seal or burns.The pouch seal exhibited signs of a weak heat bond/incomplete sealing.Comparison of the seal to an in-house unit showed that the returned seal was more transparent, whereas the in-house unit was more opaque.This is consistent with the condition observed in the customer provided images.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the weak seal, but this is consistent with insufficient heat during the sealing cycle.
Event or Problem Description
As reported: after opening the outer packaging of the product, it was found that the inner packaging was not completely sealed.After replacing with another product of the same specification, procedure was performed.After comparing with other products of the same specifications, it was found that the sealing marks on the two ends of the package were relatively shallow.No patient involvement.Patient status is normal.

• Brand Name: HEADWAY-17 XSUPPORT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20413570
• Report Number: 2032493-2024-00748
• Device Sequence Number: 12859577
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)240618(17)270531(10)0000629846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: MC172150SX
• Device Lot Number: 0000629846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown