MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; EMBOLIZATION COIL

Model Number	100728HFRM-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
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.The device has been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that resistance was encountered during advancement of the coil in the microcatheter.The coil was removed and checked.A second attempt was made to advance the coil in the microcatheter; however, resistance was encountered and the coil got stuck.During removal, the coil detached.Both segments of the coil were removed in their entirety.There was no reported intervention or patient injury.The patient was reported to be good.
Additional Manufacturer Narrative
The device was returned with the pusher and microcatheter for analysis; the coil was detached from the pusher.The catheter was severely damaged/pinched at two locations, 4 inches (10.16 cm) and 12 inches (30.48 cm) proximal of the distal tip of the microcatheter.The body coil of the pusher was noted to have overlap damage.The heater coil was damaged longitudinally, with some damage observed on the strain relief tip.The strain relief did not contain any burn marks, which indicate the heater coil was not activated.The attachment monofilament could not be found within the distal portions of the pusher, nor could it be seen in the attachment bond area.The introducer tip was noted to be damaged.An x-ray machine was used to investigate whether and where the coil was stuck in the microcatheter.The distal tip of the implant was located approximately 16.5 inches (42 cm) proximal of the distal tip of the microcatheter.No damage via x-ray was seen to the coil and the proximal end of the implant.The inner diameter of the microcatheter seems to narrow on a portion of the distal area of the implant, and continues to be narrow up to the distal tip of the implant.The proximal end of the implant coil was retrieved and exposed for investigation.The proximal end of the implant was noted to be stretched, and the tie knot area was damaged but was still visible.The point of break found on the attachment monofilament looked to be a stretched tail which indicates the breakage was due to over specification of force.The uv glue at the tie knot area was cleared for investigation, and showed the tie knot was stretched but still intact.There were no other notable observations.Based on the reported details and investigation findings, the complaint could be confirmed.The decreased the inner diameter of the microcatheter impeded the advancement of the coil, and allowed for the coil to advance enough where it became stuck.The exact root cause is unknown; however, the damage to the device exhibited evidence that it was subjected to excessive tensile force that exceeded the maximum strength specification of the monofilament.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7594610
• Report Number: 2032493-2018-00111
• Device Sequence Number: 10804890
• Product Code: HCG
• UDI-Device Identifier: 00816777023575
• UDI-Public: (01)00816777023575(11)171109(17)221031(10)1711095YB
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: 10/31/2022
• Device Model Number: 100728HFRM-V
• Device Lot Number: 1711095YB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR