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

Catalog Number	RBY2C0420-A
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	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pusher assembly of the ruby coil was wrapped around the device multiple times.The pusher assembly and introducer sheath of the ruby coil were bent in multiple locations throughout their lengths; the embolization coil was detached from the pusher assembly and damaged.Evaluation of the returned devices revealed the lantern was ovalized near the distal tip.This type of damage typically occurs due to forceful gripping or otherwise compressing the lantern during insertion into the patient.The ovalized lantern likely contributed to the resistance experienced by the physician when attempting to advance the ruby coils out of the lantern.Further evaluation revealed that all components of all three ruby coils were damaged.This damage was likely incidental and likely occurred due to improper handling during packaging for return.All penumbra coils and catheters 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: 3005168196-2016-01129, 3005168196-2016-01130, 3005168196-2016-01132.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician inserted the lantern through another manufacturer's sheath and into the patient.While advancing three ruby coils out of their introducer sheaths and into the lantern, the physician encountered resistance.Subsequently, all three ruby coils became stuck at the same location and were unable to advance out of the lantern.Therefore, the physician removed all three ruby coils and continued the procedure by delivering another manufacturer's coils into the target vessel using the same lantern.While the physician was advancing the last non-penumbra coil through the same lantern, the coil became stuck in the lantern.Therefore, the lantern and coil were removed and the procedure was completed using another manufacturers'' microcatheter and coils.There were no observed damages to the lantern after removal from the patient's body.In addition, 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: 5846973
• Report Number: 3005168196-2016-01131
• Device Sequence Number: 464147
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 07/07/2016

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: 11/16/2023
• Device Catalogue Number: RBY2C0420-A
• Device Lot Number: F66543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR