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

Catalog Number	RBY4C0202
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	05/25/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked approximately 9.0, 71.0, and 76.0 cm from the proximal end.The embolization coil was detached, stretched, and displayed multiple offset coil winds.The proximal constraint sphere and fractured stretch resistant (sr) wire were present inside the ddt.There was clotted blood on the coil, on the ddt, and inside the introducer sheath.Conclusions: evaluation of the returned device revealed that the embolization coil was detached and exhibited extensive coil structure damage.This damage is likely a result of repeated attempts to advance the embolization coil against resistance.The embolization coil detachment is due to an sr wire fracture.The sr wire fracture is likely a result of forcefully retracting the coil against resistance.If an rhv and continuous flush are not used, blood may begin to clot around the device inside the non-penumbra microcatheter and may contribute to any resistance felt by the physician.Further evaluation revealed kinks in pusher assembly.These kinks were likely incidental and occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right gastric artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and the ruby coil would not advance through the distal end of the microcatheter.Therefore, the ruby coil was removed and the procedure was completed using additional 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: 6699442
• Report Number: 3005168196-2017-01133
• Device Sequence Number: 19078911
• Product Code: HCG
• UDI-Device Identifier: 00814548013121
• UDI-Public: 00814548013121
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/12/2017

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: 09/25/2024
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F71772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1