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

Catalog Number	RBY2C0430
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2016
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 using ruby coils.During the procedure, the physician noticed under fluoroscopy that a ruby coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached coil was removed from the patient and then the entire coil was retrieved from the microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The embolization coil was detached from the ruby coil pusher assembly and had the proximal constraint sphere intact.The outer diameter (od) of the proximal constraint sphere was measured and found with be within specification.Evaluation of the returned device revealed that the embolization coil was detached from the pusher assembly and had the proximal constraint sphere intact.The od of the proximal constraint sphere was found to be within specification.The ruby coil pusher assembly and microcatheter mentioned in the complaint were not returned for evaluation.Since the ruby coil pusher assembly was not returned for evaluation, the root cause of the unintentional detachment could not be determined.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: 6087774
• Report Number: 3005168196-2016-01572
• Device Sequence Number: 758058
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/10/2016

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: 06/15/2023
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F64420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1