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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
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: 3005168196-2019-01289.
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 placed the initial ruby coils in the target vessel using the lantern and a 5f guide catheter.While advancing the last ruby coil through the lantern, the physician experienced resistance.While attempting to retract the ruby coil for repositioning, resistance was also experienced and subsequently, the ruby coil unintentionally detached in the lantern.It was reported that part of the ruby coil unraveled in the patient¿s body.Therefore, the physician removed the guide catheter, the lantern and the detached ruby coil together.The procedure was ended at this point and no additional coil was needed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the stretch resistant wire (sr wire) was fractured and the embolization coil was unraveled.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured, and the embolization coil was unraveled.If the ruby coil is forcefully retracted against resistance, the sr wire may fracture, and the embolization coil will stretch and unravel.The lantern used in the complaint and the ruby coil pusher assembly were not returned for evaluation; therefore, the root cause of the reported resistance could not be determined.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: 8750810
• Report Number: 3005168196-2019-01288
• Device Sequence Number: 2338853
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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): 06/03/2019
• 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 Expiration Date: 05/10/2025
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F77060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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