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

Catalog Number	RBY2C0825
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
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.This report is associated with mfr report number: 3005168196-2017-00579.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (pavm) using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician did not mention feeling any resistance; however, the coil became stuck half way through the microcatheter and was unable to advance any further.The ruby coil was then removed and a new ruby coil was opened.However, the same issue occurred and the ruby coil was unable to advance through the microcatheter.Therefore, the physician removed the ruby coil and completed the procedure using additional coils and the same microcatheter.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Results: the pet lock was intact on the proximal end of the ruby coil¿s pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Conclusions: evaluation revealed that during functional analysis, both devices could be advanced through their introducer sheaths and a demonstration microcatheter without issue.The root cause of the ruby coils not being able to advance during the procedure could not be determined.Evaluation of the first ruby coil revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This was likely incidental, and likely occurred after successful withdrawal of the ruby coil from the system.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: 6487990
• Report Number: 3005168196-2017-00578
• Device Sequence Number: 16466059
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

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: 10/20/2023
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F66122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 90