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

Catalog Number	RBY2C0312
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
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 duodenal artery using ruby coils.It was noted that the patient's anatomy was tortuous.During the procedure, while being advanced through a non-penumbra microcatheter, the ruby coil unintentionally detached.Therefore, the physician removed the microcatheter containing the detached ruby coil from the patient's body and flushed out the ruby coil.The physician then reinserted the same microcatheter in the target vessel and the procedure was completed using additional ruby coils.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
Results: the embolization coil was detached and the sr wire was fractured.The proximal constraint sphere was present inside the ddt.The ruby coil pusher assembly was kinked in multiple locations and fractured approximately 71.0 cm from the hub.Conclusions: evaluation of the returned ruby coil revealed the embolization coil was detached via sr wire fracture.This damage was likely a result of retracting the embolization coil against resistance.During functional testing, a demonstration ruby coil was advanced through the returned non-penumbra catheter without issue.The root cause of the resistance experience during the procedure could not be determined.Further evaluation revealed the pusher assembly was kinked and fractured.These damages were not mentioned in the complaint and were likely incidental to the reported issue.They were likely incidental and may have occurred during packaging for return to penumbra.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: 7336214
• Report Number: 3005168196-2018-00556
• Device Sequence Number: 10783717
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• 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): 02/21/2018

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: 10/31/2024
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F72615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR