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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
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 numbers: 3005168196-2018-024; 3005168196-2018-024.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the collaterals between the aorta and pulmonal artery using pod packing coils (podjs) and ruby coils.During the procedure, the physician felt resistance while advancing the first 30cm podj through the lantern delivery microcatheter (lantern) into the target vessel.It was reported that the podj would not advance more than 20cm out of the lantern.The podj was therefore removed.The physician then successfully placed a 15cm podj; however, while attempting to advance another 30cm podj, using the same lantern, the same resistance was experienced as with the first podj.This podj was, therefore, also removed.The physician then successfully placed another 15cm podj and two ruby coils using the same lantern.While attempting to advance another ruby coil, it would not advance out of its introducer sheath.After making further attempts to push the ruby coil through its introducer sheath, the ruby coil was still unable to exit the sheath and was removed.The procedure was completed using another ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report numbers: 3005168196-2018-02476 and 3005168196-2018-02480.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.Multiple bends were present along the length of the pusher assembly.The mid-joint of the pusher assembly was distal to the friction lock of the introducer sheath.The embolization coil was intact with the ddt of the pusher assembly.The introducer sheath was ovalized approximately 62.5cm from the proximal end of the introducer sheath (2.5 cm from the distal end).Conclusions: evaluation of the returned podjs revealed offset coil winds and detached embolization coils.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The lantern was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Further evaluation revealed the podjs¿ embolization coils were detached.This damage is likely incidental to the reported complaint and likely occurred when the device pusher assemblies were retracted through the introducer sheath friction lock.The pusher assembly bends on the returned devices may have been due to forcefully advancing against the resistance experienced during the procedure or packaging for return to penumbra.Evaluation of the returned ruby revealed an ovalization on the introducer sheath.During functional testing the device was able to be advanced through its introducer sheath with minor resistance but was unable to retract back through the ovalization portion of the sheath.This ovalization likely contributed to the resistance experienced during the procedure.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.This report is associated with mfr report numbers: 3005168196-2018-02476 and 3005168196-2018-02480.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8189287
• Report Number: 3005168196-2018-02481
• Device Sequence Number: 11329325
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/21/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2025
• Device Catalogue Number: RBY4C0204
• Device Lot Number: C08447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 02/27/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/21/2018; 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 7
• Date Report Sent to FDA: 01/01/2005