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

Catalog Number	RBY4C0305
Medical Device Problem Codes	Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly and stuck in the introducer sheath friction lock, and the stretch resistant wire (sr wire) was separated from the distal end of the embolization coil.Conclusions: evaluation of the returned device revealed the pusher assembly was kinked in multiple locations throughout its length.These kinks were likely due to return packaging conditions, as the specimen bags that the ruby coil was returned in were folded at the start of evaluation.Further evaluation revealed the embolization coil was detached from the pusher assembly and the sr wire was separated from the distal end of the embolization coil.The introducer sheath has a friction lock on the proximal end.The 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allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the embolization coil is forcefully withdrawn beyond the introducer sheath friction lock, the sr wire may separate from the embolization coil, which will allow the embolization coil to detach from the pusher assembly.This damage was likely incidental and likely occurred after successful retraction of the ruby coil from the microcatheter.Due to the incidental damage on the pusher assembly and embolization coil, the root cause of the resistance experienced during the procedure could not be determined.The non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.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 procedure using ruby coils.During the procedure while attempting to advance a ruby coil through another manufacturer¿s microcatheter, the physician experienced resistance and the ruby coil became stuck; therefore, the ruby coil was removed.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: 6456714
• Report Number: 3005168196-2017-00532
• Device Sequence Number: 562973
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 03/07/2017

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: 12/27/2024
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F73401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR