MAUDE Adverse Event Report: MICROVENTION, INC AZUR DETACHABLE FRAMING COIL; EMBOLIZATION COIL

Model Number	45-652050
Medical Device Problem Codes	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	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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 been returned to the manufacturer.The investigation is currently underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization of a splenic artery aneurysm, the implant coil became stuck after encountering resistance during advancement.During retraction of the delivery pusher, it was noticed that the implant coil may have become detached.The delivery pusher was removed, and the coil was not present at the tip.An attempt was made to advance the implant coil into the aneurysm with the guidewire, but the coil was stuck in the microcatheter.The detached coil was removed in its entirety together with the microcatheter.Approximately half of the detached coil was protruding from the tip of the microcatheter.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The delivery pusher and implant coil were returned for analysis.The dispenser hoop and microcatheter were not returned.The pusher was bent at the proximal section (connector section).The pusher's distal section was damaged, the heater coil section was kinked, and the strain relief section (pet) was folded and broken.The distal coil was smashed.The implant coil was stretched at the tie knot section and had blood residual.The implant coil was kinked at distal section.The unit was dissected to review the monofilament, and it was found broken; this condition can be produced when the implant is stuck and the pusher is retracted, producing the monofilament damage.The reported complaint is confirmed.The physical evaluation of the returned coil system found the implant to be damaged and stretched, and the pusher was damaged and bent in multiple locations.The bend damages are consistent with the device becoming stuck while continued advancing force is applied to the device to overcome the friction.The stretching to the implant is typical of the device experiencing retraction forces that exceed the tensile strength of the coil.The implant was returned separated from the pusher and the profile of the monofilament is consistent with a tensile break.The investigation of the returned device could not determine how or what caused the device to become stuck, but the damages are all consistent with the device experiencing forces over specification.The introducer and microcatheter were not returned, so the investigation could not determine if either of these components caused or contributed to the reported complaint.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8880683
• Report Number: 2032493-2019-00186
• Device Sequence Number: 2128782
• Product Code: KRD
• UDI-Device Identifier: 00810170016158
• UDI-Public: (01)00810170016158(11)190302(17)240229(10)19030251V
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 02/29/2024
• Device Model Number: 45-652050
• Device Catalogue Number: 45-652050
• Device Lot Number: 19030251V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR