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

Catalog Number	RBY2C0825-A
Medical Device Problem Codes	Retraction Problem (1536); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
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 kinked approximately 5.0 cm from the proximal end.The introducer sheath was ovalized approximately 6.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and kinked throughout its length.Conclusions: evaluation of the returned device revealed the introducer sheath was ovalized.This damage likely occurred due to overtightening of a rotating hemostasis valve (rhv) this ovalization likely contributed to the inability to withdraw the ruby coil into the introducer sheath.Further evaluation revealed the pusher assembly and embolization coil were kinked.This damage likely occurred due to forceful manipulation of the ruby coil against resistance.Ruby coils are 100% functionally evaluated during in-process inspection.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 using ruby coils.During the procedure, the physician deployed a ruby coil into the patient but noticed that the ruby coil was too large for the target vessel and decided to remove the coil to use in another area.However, while the physician was attempting to resheath the ruby coil, it would not retract back into its orange sheath and could not be used.The procedure was successfully completed using a new ruby coil.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: 5510510
• Report Number: 3005168196-2016-00334
• Device Sequence Number: 519624
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• 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): 02/22/2016

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: RBY2C0825-A
• Device Lot Number: F66122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2016
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR