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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Kinked (1339); Sticking (1597); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-01400.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician felt resistance advancing a ruby coil through the tip of a non-penumbra microcatheter; consequently, the ruby coil became kinked.The ruby coil and microcatheter was therefore removed and, upon removal, it was found that the microcatheter was kinked.A new microcatheter was placed, and the technician accidentally kinked a second ruby coil while advancing it into the microcatheter; therefore, the ruby coil was removed and re-sheathed.The ruby coil became sticky within the introducer sheath because it had not been cleaned upon removal; therefore, it could not be advanced out of the introducer sheath and into the microcatheter.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: 6810314
• Report Number: 3005168196-2017-01399
• Device Sequence Number: 11005093
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/24/2017

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: 02/19/2025
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F74515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR