MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL PUSHABLE 10MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-251020
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that the labels on the outer box and the sterile packaging containing the product indicated the coil size was 10mm x 20cm; however, the plastic tab on the end of the coil dispenser indicated the coil size was 16mm x 20cm.The coil was initially inserted into the microcatheter, but removed before it was placed into the patient's anatomy, as the coil size was questionable.There was no reported patient injury.
Additional Manufacturer Narrative
The implant, introducer sheath, push tool, and packaging were returned for analysis.Investigation into the returned device found the implant to be loose in the pouch.The implant was kinked in multiple locations throughout its length.The kinking and nature of the gel/returned condition did not allow for accurate measurement of the loop diameters.As a result, the sizing of the lead loop could no longer be verified.The length of the implant was verified to be 20cm.The introducer hub was marked 16x20, where the product packaging noted 10x20.Based on the investigation findings and available information, the reported complaint is confirmed.The returned packaging was marked as 10x20, where the hub was marked as 16x20.Sizing of the product could only accurately confirm the length due to damage preventing accurate measurement of the implant's loop diameter.The physical evaluation of the returned components could only confirm the dimensions on the package did not match the dimensions on the hub; the inspection could not determine the conditions or circumstances that led to this mismatch.The findings from this investigation have been communicated to quality.

• Brand Name: AZUR 35 HYDROCOIL PUSHABLE 10MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9925604
• Report Number: 2032493-2020-00091
• Device Sequence Number: 3296702
• Product Code: KRD
• UDI-Device Identifier: 00810170017452
• UDI-Public: (01)00810170017452(11)180801(17)210731(10)180801529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 45-251020
• Device Catalogue Number: 45-251020
• Device Lot Number: 180801529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1