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

Catalog Number	RBY4C1240-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was bent in multiple locations throughout its length.The embolization coil was partially hanging out of the distal end of the introducer sheath, detached from the pusher assembly, and damaged throughout its length.The proximal constraint sphere was inside the distal detachment tip (ddt), and the stretch resistant (sr) wire was fractured.Conclusions: evaluation of the returned devices revealed that the embolization coils were detached from their pusher assemblies, and their stretch resistant (sr) wires were fractured.If a ruby coil is forcefully withdrawn against resistance, the sr wire may fracture, which would allow the embolization coil to detach.Further evaluation revealed both pusher assemblies and both embolization coils were damaged.This type of damage typically occurs due to forceful manipulation of the ruby coil against resistance.The damage found on the pusher assemblies may also have occurred during packaging for return.Since the embolization coils were detached and the ruby coils were severely damaged, functional analysis of the ruby coils could not be completed.However, the failed functional testing of the non-penumbra microcatheter suggests that it was dimensionally incompatible with the ruby coils.Further evaluation of the non-penumbra microcatheter revealed it was bent in multiple locations throughout its length.If a ruby coil is used with a damaged microcatheter, the user may experience resistance upon attempting to advance the ruby coil.Ruby coils are 100% functionally and visually evaluated during in-process inspection.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 number: 3005168196-2016-00272.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to advance two ruby coils through another manufacturer's microcatheter and they were both removed.The procedure was completed using new ruby coils and another manufacturer's coils.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: 5478089
• Report Number: 3005168196-2016-00271
• Device Sequence Number: 281881
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/03/2016

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: 10/20/2023
• Device Catalogue Number: RBY4C1240-A
• Device Lot Number: F66127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Initial Report FDA Received Date: 03/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1