MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Catalog Number	RBY2C1460
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician advanced the first ruby coil into the target vessel using a non-penumbra microcatheter when it unintentionally detached.The ruby coil was successfully retrieved using a snare device, and was removed.The procedure was completed using another ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact with the proximal end of the pusher assembly.The pull wire and pet bump were distal to the distal detachment tip, and the pet bump material was damaged (ddt).The proximal constraint sphere was separated from the pusher assembly ddt and the detached embolization coil.The embolization coil was covered in dried blood and was damaged.The overall pusher length was approximately 172.5 cm.Conclusions: evaluation of the returned ruby coil revealed the pet lock was intact, the embolization coil was detached, and the pull wire was distal to the ddt.If the pusher assembly elongates past the reach of the pull wire, the embolization coil will likely become detached.This is further supported by the pull wire being distal to the ddt.If the pull wire retracts out of the alignment feature, the precompression can relax causing the pull wire to protrude from the ddt.Further evaluation revealed a damaged embolization coil.If the device is forcefully retracted against resistance, damage such as offset coil winds may occur.The root cause of the initial resistance was unable to be determined.Some of the damage to the embolization coil is likely incidental to the complaint and may have occurred during the reported attempts to retrieve the coil with a snare device.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8219014
• Report Number: 3005168196-2019-00020
• Device Sequence Number: 197538
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 12/06/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2026
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F81936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Date Report Sent to FDA: 01/01/2005