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

Catalog Number	RBY2C0530
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached and the stretch resistant wire (sr wire) was fractured.Clotted blood was present inside the introducer sheath.The pusher assembly was kinked approximately 5.0, 14.0, and 127.0 cm from the hub.Conclusions: evaluation of the returned ruby coil revealed the embolization coil was detached due to a sr wire fracture.This damage was likely a result of retracting the coil against significant resistance.Further evaluation revealed coagulated blood on the embolization coil and within the introducer sheath.If continuous flush is not used during the procedure, blood may begin to coagulate on the embolization coil and inside the introducer sheath.This coagulated blood likely contributed to the resistance experienced and the eventual fracture of the sr wire.Further evaluation also revealed the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have 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 to treat a gastrointestinal (gi) bleed using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and friction; therefore, the physician decided to pull the ruby coil out.However, the ruby coil unintentionally detached outside of the hub of the microcatheter.Therefore, the physician pulled the remainder of the ruby coil out and the procedure was completed using additional 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: 6979776
• Report Number: 3005168196-2017-01887
• Device Sequence Number: 1880156
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2017

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: 02/25/2025
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F74632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial 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: 8 MO