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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked and fractured along its length.Conclusions: evaluation of the ruby coils revealed an extensively damaged pusher assemblies.The embolization coil and non-penumbra catheter used during the procedure were not returned for evaluation.The root cause of the reported issue could not be determined due to extensive damage upon return.The majority of this damage was likely incidental and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report numbers: 3005168196-2018-00894.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric and splenic artery using ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a ruby coil within the microcatheter, and therefore the physician removed the ruby coil, despite feeling resistance while retracting.This same issue then occurred with a second ruby coil.The procedure was completed using new ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7473749
• Report Number: 3005168196-2018-00893
• Device Sequence Number: 18871990
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 04/03/2018

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: 10/30/2025
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F80300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR