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

Catalog Number	RBY2C0420
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
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, the physician felt resistance advancing the ruby coil through the non-penumbra microcatheter and, therefore, attempted to retract the coil.The ruby coil unintentionally detached and then began unraveling within the microcatheter; therefore, the physician removed the microcatheter with the unraveling and detached coil inside.The procedure was completed using the same non-penumbra microcatheter and other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was fractured approximately 66.0 cm from the proximal end.The pusher assembly was kinked in multiple locations.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.Conclusion: evaluation of the returned device revealed that the sr wire was fractured.This type of damage likely occurred due to forceful retraction against resistance.The root cause of the resistance felt during advancement could not be determined.Further evaluation of the returned device revealed that the pusher assembly was fractured and kinked in multiple locations.The fracture likely occurred due to forceful handling during use.The kinks were likely incidental and may have occurred while packaging the device for return.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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: 6303714
• Report Number: 3005168196-2017-00154
• Device Sequence Number: 10887735
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/09/2017

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: 06/27/2024
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F70363
• 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: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR