MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-450415
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer.The investigation is underway.
Event or Problem Description
It was reported that during a tips procedure, the coil did not take shape right away as it was advanced into a varix.The coil was allowed to soften and the coil took shape nicely during the second attempt; however, the last portion of the coil could not be advanced out of the catheter tip.The coil was pulled and pushed "fairly hard," however, it would not advance out of the catheter.The pusher wire was removed and then the entire system was removed.Upon inspection outside the patient, the coil was noted to have detached in the catheter.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher, coil, and catheter were returned for analysis; the implant was found detached from the pusher.The distal body coil portion of the pusher was bent, possibly same shape as the catheter tip.The distal glue joint on the outer sleeve was broken.The heater coil and stain relief were damaged.The heater coil was somewhat compressed and bent.The strain relief was folded outwards.The distal lumen of the heater coil did not look smashed or pinched.The implant was found detached from the pusher, coiled up with the gel separating off the implant in clumps.An attachment monofilament tail was observed at the proximal end of the implant.The tip of the monofilament tail was stretched.The catheter tip did not show any notable damages.The distal portion of the pusher was cut open to remove the attachment monofilament for further evaluation.The monofilament tip was noted to be stretched.Based on the investigation analysis and available information, the complaint was able to be confirmed.The implant was found detached from the pusher, and most likely detached due to experiencing over specification of pull force as suggested by the physical appearance of the attachment monofilament stretched tips.For the implant to experience over specification of pull force, it most likely became stuck, which was indicated in the complaint.Damage to the distal glue joint suggests over specification of pull force on the device as well.There were no indications on the catheter that could have caused the implant to become stuck.The implant coil does not have any notable signs or damages that could have caused the resistance as well.The root cause of why the implant became stuck could not be determined.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8487998
• Report Number: 2032493-2019-00083
• Device Sequence Number: 1871350
• Product Code: KRD
• UDI-Device Identifier: 00810170014901
• UDI-Public: (01)00810170014901(11)180604(17)230531(10)18060451A
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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): 03/15/2019

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: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 45-450415
• Device Catalogue Number: 45-450415
• Device Lot Number: 18060451A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61