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

Catalog Number	RBY2C0430
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician noticed that the ruby coil was unable to advance out of the microcatheter despite multiple attempts; therefore, the ruby coil was removed and resheathed.The procedure was completed using the same non-penumbra microcatheter and new ruby coils.The physician reported not using a rotating hemostasis valve and continuous flush was not maintained during the procedure.There was no report of an adverse effect to the patient.
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 45.0 and 92.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the introducer sheath was full of blood.When the blood was flushed out of the introducer sheath by a penumbra investigator, the ruby coil could be advanced through its introducer sheath and a demonstration microcatheter without issue.Blood in the introducer sheath and microcatheter may have contributed to the inability to advance the ruby coil during the procedure.Further evaluation revealed the pusher assembly was kinked.This damage may have occurred due to forceful handling of the ruby coil during insertion into the non-penumbra microcatheter.The non-penumbra microcatheter mentioned 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6045694
• Report Number: 3005168196-2016-01480
• Device Sequence Number: 19054984
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 09/20/2016

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: 06/29/2023
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F64672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR