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

Catalog Number	RBY2C1660
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	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 renal artery using ruby coils.It was reported that while removing the ruby coil from the packaging hoop, it came off the introducer sheath; however, the physician put the ruby coil back into its introducer sheath.During the procedure, the physician experienced strong resistance while advancing the ruby coil through the hub of the lantern delivery microcatheter (lantern), therefore, the ruby coil was removed.The procedure was completed using new ruby coils, a pod packing coil (podj) and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report.Results: the pet lock was intact on the proximal end of its pusher assembly.The embolization coil was intact with its pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and the sheath had coagulated blood inside.The introducer sheath was ovalized approximately 3.0 cm from the distal tip.Conclusions: evaluation of the returned ruby coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This likely occurred while re-sheathing the ruby coil after it was removed from its packaging hoop.This also may have contributed to the reported resistance while attempting to advance the ruby coil through the hub of the lantern.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath and the ruby coil could not be advanced any further.The root cause of the introducer sheath coming off while removing the ruby coil from its packaging hoop could not be determined.Further evaluation of the returned ruby coil revealed that the distal tip of the introducer sheath was ovalized.The ovalization was likely incidental to the reported complaint.The lantern identified in the complaint was not returned for evaluation.Penumbra coils are visually 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 report and is being corrected on this follow-up #01 mfr report:3005168196-2019-01705.1.Section g.Box 4.Date received by manufacturer 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: 8970582
• Report Number: 3005168196-2019-01705
• Device Sequence Number: 16967831
• Product Code: HCG
• UDI-Device Identifier: 00814548019253
• UDI-Public: 00814548019253
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2019
• 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: 08/26/2026
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F85521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 01/14/2005; 09/26/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 09/19/2019; 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005