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

Catalog Number	RBY2C0520
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
Results: the proximal constraint sphere was intact and the stretch resistant (sr) wire was not fractured.The embolization coil had several offset coil windings along its length.The maximum outer diameter (od) was measured and found to be within product specification.The ruby coil was unintentionally detached and, therefore, was unable to be functionally tested.Conclusions: evaluation of the returned device revealed that the embolization coil was damaged in multiple locations along its length.This damage is likely a result of repeated manipulation of the embolization coil against resistance.The proximal constraint sphere was intact on the proximal end of the embolization coil and the sr wire was not fractured.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.In addition, the pusher assembly was not returned for evaluation, and therefore, the root cause 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while the physician was advancing a ruby coil through another manufacturer's microcatheter, the coil unintentionally detached inside the microcatheter.Therefore, the ruby coil was removed and the procedure was completed using five new ruby coils.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: 6087856
• Report Number: 3005168196-2016-01571
• Device Sequence Number: 16383186
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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: 12/06/2023
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F66838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1