MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; EMBOLIZATION COIL

Model Number	100308H2HS-V
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
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 has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that upon removal from the outer box, the pouch containing the sterile embolization coil was found to be unsealed.The device was not used in the patient.
Additional Manufacturer Narrative
The device was received for evaluation.The unit was inside of the pouch, which was unsealed; however, the impression of the sealing jaws were evident on the pouch, indicating that the pouch had gone through the sealing process.The dispenser hoop, pusher, introducer and implant coil were undamaged and appeared to be within specification.The reported complaint is confirmed.The investigation of the returned device found the pouch to be open; however, the impression of the sealing jaws were evident on the pouch, indicating that the pouch had gone through the sealing process.The build record for the lot was found to be complete and accurate.The pouch seal is inspected in-process by manufacturing and 100% by quality control.In addition, the pouch seal strength is monitored routinely as part of the pouch sealing process using peel test and burst test.There have been no other complaints associated with this lot.The findings from this investigation have been communicated to manufacturing and quality.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9599336
• Report Number: 2032493-2020-00010
• Device Sequence Number: 2499618
• Product Code: HCG
• UDI-Device Identifier: 00810170019579
• UDI-Public: (01)00810170019579(11)180118(17)221231(10)1801181N4
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Expiration Date: 12/31/2022
• Device Model Number: 100308H2HS-V
• Device Catalogue Number: 100308H2HS-V
• Device Lot Number: 1801181N4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1