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

Catalog Number	RBY2C0520-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2016
Type of Reportable Event	Malfunction
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 deployed a ruby coil into the aneurysm using another manufacturer's microcatheter and visually confirmed that the ruby coil was detached from the end of the ruby coil pusher assembly.However, the physician did not verify with fluoroscopy that the coil was detached when he pulled the pusher assembly out of the microcatheter.Once the pusher assembly was removed, the physician noticed under fluoroscopy that the ruby coil was not in the target vessel.Upon inspecting the hub of the microcatheter, the physician noticed that the ruby coil was hanging out from the end of it.The procedure was completed using six new ruby coils and the same microcatheter.There was no report of and adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was broken of the proximal end of the pusher assembly; the stretch resistant (sr) wire of the embolization coil was fractured, and the proximal constraint sphere was missing.The coil was detached from the pusher assembly.The pull wire was completely retracted out of the distal detachment tip (ddt).The proximal end of the coil was measured and found to be within specification.Conclusion: evaluation of the returned device confirmed that the pet lock on the proximal end of the ruby coil pusher assembly was broken.A broken pet lock typically occurs during an attempt to detach the coil during deployment.If a pull force is applied to the pull tube on the proximal end of the pusher assembly, by design the pet lock should break and the coil should detach.If the device is in tortuous anatomy, friction inside the hypotube of the pusher assembly may prevent the pull wire from retracting out of the distal detachment tip (ddt), even if separation of the pet lock is observed.Further evaluation revealed that the sr wire was fractured.If the device is retracted once the embolization coil is deployed in the targeted vessel, but the embolization coil is still attached to the pusher assembly, damage such as a sr wire fracture may occur.Sr wire fracture may cause the embolization coil to detach.The proximal end of the coil was measured and found to be within specification.Ruby coils are 100% functionally tested during in-process inspection.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: 5621216
• Report Number: 3005168196-2016-00580
• Device Sequence Number: 87830
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2016

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: Physician
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: RBY2C0520-A
• Device Lot Number: F67709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR