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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was kinked approximately 5.0 cm from the proximal end.The complaint does not involve device functionality.Therefore, no functional testing was performed.Conclusions: evaluation of the returned ruby coil revealed that the device was kinked on its proximal end.This damage was likely a result of mishandling upon removal from the packaging hoop.The microcatheter cited in the complaint and coil introducer sheath were 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
While preparing a ruby coil for an embolization procedure, the technologist noticed that the ruby coil pusher assembly was kinked upon removal from the packaging.The kinked pusher assembly was found prior to use and therefore, the ruby coil was set aside and not used in the procedure.The procedure was completed using additional ruby coils.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7007376
• Report Number: 3005168196-2017-01944
• Device Sequence Number: 1601339
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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: Radiologic Technologist
• Device Expiration Date: 06/27/2025
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F77950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1