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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
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 splenic artery using ruby coils.During the procedure, the physician experienced resistance while advancing a ruby coil through a non-penumbra microcatheter and, therefore, the physician attempted to retract the ruby coil.However, while retracting the ruby coil, it unintentionally detached within the microcatheter.The physician then removed the microcatheter with the detached ruby coil inside from the patient and the procedure was completed using a new microcatheter and new coils.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 pusher assembly.The pusher assembly was kinked approximately 10.0 and 45.0 cm from the proximal end.The embolization coil stretch resistant wire (sr wire) was fractured and the embolization was detached from its pusher assembly.The proximal constraint sphere was inside the ddt.The ruby coil¿s embolization coil was detached from its pusher assembly and, therefore, the ruby coil could not be functionally tested.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured.If the device is forcefully retracted against resistance the sr wire may fracture.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation; therefore the root cause of the resistance could not be determined.If the sr wire fractures, it will allow the embolization coil to detach.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: 7729059
• Report Number: 3005168196-2018-01474
• Device Sequence Number: 13770359
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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): 07/04/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 01/14/2026
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F81407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005