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

Catalog Number	RBY4C1035
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician successfully implanted two ruby coils into the target vessel using a non-penumbra microcatheter.While advancing the third ruby coil into the microcatheter, the physician encountered resistance and decided to retract the ruby coil.Upon retracting the ruby coil approximately three fourths of the way back into its introducer sheath, it detached from its pusher assembly within its introducer sheath.Therefore, the ruby coil was removed.The procedure was completed using ten additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated, and the pull tube was fractured on the proximal end of the pusher assembly.The pusher assembly had bends along its length.The pull wire was not within the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and had offset coils winds throughout its length.Conclusions: evaluation of the returned ruby coil revealed the pet lock on the proximal end of the pusher was separated and the pull tube was fractured.If the proximal end of the pusher assembly is manipulated and the pet lock becomes separated, the pull wire may retract from the ddt and allow the embolization coil to detach.Further evaluation revealed pusher assembly bends and offset coil winds along the length of the embolization coil.These damages were likely incidental to the reported complaint.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: 9234504
• Report Number: 3005168196-2019-01988
• Device Sequence Number: 13539526
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• 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
• Report Date (Section B): 09/26/2019
• 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 Catalogue Number: RBY4C1035
• Device Lot Number: F86874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005