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

Catalog Number	RBY2C0305
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
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.This report is associated with mfr report number: 3005168196-2019-01723.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and penumbra smart coils (smart coils).During the procedure, a ruby coil would not advance within its introducer sheath; therefore, it was removed.The physician resumed the procedure and successfully placed another ruby coil in the target vessel.The physician then advanced a smart coil which ¿would not coil;¿ therefore, it was removed.The physician resumed the procedure again and successfully placed another smart coil.The procedure was continued and completed using penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pull tube was fractured.Kinks were present throughout the length of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock, the pusher assembly was fractured, and the embolization coil was detached from the pusher assembly.If the mid-joint is retracted proximal to the introducer sheath friction lock, resistance may be experienced.If the smart coil is forcefully advanced against resistance, damage such as a pusher assembly fracture may occur.If the pusher assembly fractures, the pull wire will likely retract out of the pusher assembly distal detachment tip (ddt) and allow the proximal constraint sphere to release, detaching the embolization coil.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported complaint.Evaluation of the returned ruby coil pusher assembly revealed the pet lock was separated, the pull tube was fractured, and pusher assembly kinks.These damages were not mentioned in the reported complaint and were likely incidental.The introducer sheath and embolization coil were not returned for evaluation; therefore, the root cause of the inability to advance the ruby coil during the procedure could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the reported difficulty to advance on ruby coil.This report is associated with mfr report number: 3005168196-2019-01723 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8984789
• Report Number: 3005168196-2019-01724
• Device Sequence Number: 365178
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2024
• Device Catalogue Number: RBY2C0305
• Device Lot Number: C10753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005