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

Catalog Number	RBY4C0201
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
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.This report is associated with mfr report number: 3005168196-2017-01428.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a renal bleed using ruby coils.It was noted the patient¿s anatomy was somewhat tortuous.During the procedure, while attempting to advance two ruby coils out of the non-penumbra microcatheter, the physician experienced resistance and both coils would not advance pass the same point in the microcatheter.Therefore, the ruby coils were removed and the procedure was completed using the same microcatheter, a plug and two additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The embolization coils to both ruby coils were intact with their respective pusher assemblies.There was no visible damage to the ruby coils.Evaluation of the returned devices revealed that both ruby coils could be advanced through a demonstration microcatheter without issue.Therefore, the inability to advance the ruby coils could not be confirmed.The tortuous patient anatomy likely contributed to the resistance experienced during the procedure.The non-penumbra microcatheter mentioned in the complaint was not 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: 6815517
• Report Number: 3005168196-2017-01427
• Device Sequence Number: 163060
• Product Code: HCG
• UDI-Device Identifier: 00814548013114
• UDI-Public: 00814548013114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 04/17/2025
• Device Catalogue Number: RBY4C0201
• Device Lot Number: F75733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR