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

Catalog Number	RBY2C0725
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
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 left gastric vein using ruby coils.During the procedure, the physician successfully deployed and detached two ruby coils using a px slim delivery microcatheter (px slim).The physician then experienced resistance and was unable to advance another ruby coil out of its introducer sheath and into the px slim; therefore the ruby coil was removed.The procedure was completed using the same px slim and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 126.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Further evaluation revealed the pusher assembly was kinked.This damage likely occurred due to forceful advancement of the ruby coil against resistance after the pusher mid-joint was retracted proximal to the friction lock.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters are inspected during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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #03 mfr report: 1.Report source.Please note that the following section was incorrectly reported on follow-up #02 report and is being corrected on this follow-up #03 mfr report: 1.Conclusion code.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6579268
• Report Number: 3005168196-2017-00771
• Device Sequence Number: 16424875
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): Y
• Initial Reporter Country: LO
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2017
• 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: Physician
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F67793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 06/27/2017; 01/14/2005
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/27/2017; 07/27/2017; 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005