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

Catalog Number	RBY2C1857
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: two introducer sheaths were loaded onto the ruby coil.The embolization coil was intact with the pusher assembly and compressed.The embolization coil was stuck in the friction lock of the distal introducer sheath.There was significant amounts of blood on the embolization coil inside the distal introducer sheath.Conclusions: evaluation of the returned ruby coil revealed the pusher assembly was retracted through the introducer sheath such that the embolization coil had become stuck within the friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the ruby coil mid-joint or embolization coil is retracted past the introducer sheath friction lock, significant resistance will be experienced upon attempting to re-advance the ruby coil.Further evaluation revealed a second introducer sheath on the pusher assembly that was proximal to the sheath with the coil present inside its friction lock.Penumbra coils are 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.
Event or Problem Description
The patient was undergoing a coil embolization to treat a pelvic arteriovenous malformation using ruby coils.During the procedure, the physician placed multiple ruby coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new ruby coil into the microcatheter, the physician was unable to advance the coil out of its introducer sheath and into the microcatheter.Therefore, the ruby coil was removed and an attempt was made to advance the coil out of its introducer sheath on the back table; however, the ruby coil would still not advance out of its sheath.Thereafter, the procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7021201
• Report Number: 3005168196-2017-02007
• Device Sequence Number: 1851294
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 02/19/2025
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F74501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR