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

Catalog Number	RBY2C0930
Medical Device Problem Codes	Bent (1059); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2016
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 to treat a right hypogastric aneurysm using ruby coils.During the procedure, while advancing a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced resistance after advancing 1/3 of the ruby coil out of the lantern.Subsequently, the physician bent the coil pusher assembly; therefore, the entire ruby coil was removed from the lantern.The procedure was completed using another manufacturer¿s coils and the same lantern.It should be noted that the physician used a rotating hemostasis valve (rhv) and used continuous flush.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 bent approximately 78.0 and 80.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the ruby coil was stuck in its introducer sheath due to dried blood.When the dried blood was flushed out, the ruby coil could advance through its introducer sheath and a demonstration microcatheter without issue.Blood in the introducer sheath and lantern may have contributed to the resistance experienced when advancing the ruby coil during the procedure.Further evaluation revealed the pusher assembly was bent.This damage may have occurred due to forceful handling of the ruby coil during advancement.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection.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: 6118881
• Report Number: 3005168196-2016-01666
• Device Sequence Number: 1056878
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 10/25/2016

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: 01/10/2024
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F67456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• 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: 81 YR