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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was intact with the pusher assembly and compressed throughout its length, with the stretch resistant wire (sr wire) wrapped around the distal detachment tip (ddt).Conclusions: evaluation of the returned device revealed the embolization coil was compressed.This type of damage typically occurs due to forceful advancement of the ruby coil against resistance.The initial cause of resistance could not be determined, but the compression of the embolization coil prevented the ruby coil from advancing out of its introducer sheath during functional testing.Further evaluation 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 referenced 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 in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil through a non-penumbra microcatheter, and therefore the ruby coil was removed.The procedure was completed using two 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: 7392263
• Report Number: 3005168196-2018-00672
• Device Sequence Number: 1092771
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/06/2018

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: 11/16/2023
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F66540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR