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

Catalog Number	RBY2C0320
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	10/01/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary vein using ruby coils.During the procedure, the physician deployed and detached the initial coil in the target vessel using a lantern delivery microcatheter (lantern).While advancing a new ruby coil through the lantern, the physician experienced resistance and subsequently, the ruby coil became stuck at the distal end of the lantern; therefore, it 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
Results: the pet lock was intact with the proximal end of the pusher assembly.The introducer sheath was returned loaded backwards and the embolization coil was positioned halfway through the introducer sheath friction lock.The embolization coil had offset coil winds.The embolization coil was intact with the pusher assembly distal detachment tip.Conclusions: evaluation of the returned ruby coil revealed that the proximal end was loaded into the sheath backwards, past the friction lock.Retracting the coil past the friction lock caused offset coil wind damage.The distal two-thirds of the coil were outside of the sheath and exhibited damage which was likely a result of being returned unprotected; therefore, any damage to the coil that was present during the procedure is undiscernible from damage upon receipt.The lantern microcatheter used in the procedure was not returned for evaluation.The root cause of the reported resistance was unable to be determined due to the returned condition of the coil.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8012301
• Report Number: 3005168196-2018-02113
• Device Sequence Number: 16518895
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• 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
• Report Date (Section B): 10/01/2018
• 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: 04/29/2026
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F83149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Date Report Sent to FDA: 01/01/2005