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

Model Number	RBY2C0512-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
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 renal artery using ruby coils.During the procedure, while attempting to retract a ruby coil from a non-penumbra microcatheter for repositioning, the ruby coil unintentionally detached in the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil and flushed the coil out.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was not present on the proximal end of the ruby coil.The stretch resistant wire (sr wire) was fractured and the embolization coil was unraveled.Conclusions: evaluation of the returned ruby coil revealed the sr wire was fractured and the proximal constraint sphere was not present.This damage typically occurs if the embolization coil is forcefully advanced against resistance.If the sr wire becomes fractured the embolization coil will detach from the pusher assembly.In addition, the embolization coil will likely unravel if manipulated after an sr wire fracture.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the initial resistance could not be returned for evaluation.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: 7620477
• Report Number: 3005168196-2018-01232
• Device Sequence Number: 1422694
• Product Code: HCG
• UDI-Device Identifier: 00814548012896
• UDI-Public: 00814548012896
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2018
• 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: Physician
• Device Expiration Date: 03/27/2025
• Device Model Number: RBY2C0512-A
• Device Catalogue Number: RBY2C0512
• Device Lot Number: F75248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 01/14/2005
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 10/28/2018; 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 106
• Date Report Sent to FDA: 01/01/2005