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

Catalog Number	RBY4C1035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
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 to treat a type ia endoleak using a ruby coil.During the procedure, while placing the ruby coil in the target vessel, the physician determined that the ruby coil was oversized and decided to remove it.However, while retracting the ruby coil, it unintentionally detached in the hub of the microcatheter.Therefore, the physician pulled the detached ruby coil out of the microcatheter.The procedure was completed using three pod packing coils, fourteen other coils, and the same microcatheter.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.Bends were present on the pusher assembly approximately 16.5, 48.0, 101.0, 111.5, 121.0 and 148.5 cm from the proximal end.The pusher assembly distal detachment tip (ddt) was separated from the pusher assembly approximately 176.0 cm from the proximal end and was not returned for evaluation.Offset coil winds were present along the embolization coil.The introducer sheath was undamaged.Conclusions: evaluation of the returned ruby coil revealed the pusher assembly ddt was separated from the pusher assembly and was not returned for evaluation.If the device is forcefully manipulated against resistance, damage such as this may occur.In addition, if the pusher assembly ddt separates from the pusher assembly, the embolization coil will likely detach.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the damage could not be determined.Further evaluation revealed pusher assembly bends and offset coil winds along 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.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: 8976151
• Report Number: 3005168196-2019-01712
• Device Sequence Number: 18888772
• 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): 08/12/2019
• 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: F87214
• 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: 08/12/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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