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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil¿s pusher assembly.The stretch resistant wire (sr wire) was fractured.The embolization coil was detached from its pusher assembly, inside its introducer sheath.The ruby coil¿s sr wire was fractured and, therefore, the ruby coil was not functionally tested through a demonstration microcatheter for resistance.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured.This type of damage is likely a result of forcefully retracting the device against resistance.Due to the detached embolization coil via sr wire fracture, the device was unable to be functionally tested for tracking ability within a microcatheter.Evaluation of the returned pod packing coils (podj''s) revealed that both pusher assemblies were kinked in multiple locations.If the device is forcefully advanced against resistance, damage such as these kinks may occur.In addition, some of these kinks may have occurred while packaging the devices for return.Further evaluation of the podj with lot #f77382 revealed that the pusher assembly was fractured.This type of damage may have occurred due to an attempt to straighten an initial kink.Both podj''s were attempted to be advanced through a demonstration microcatheter and resistance was encountered as the kinks in the pusher assemblies entered the microcatheter.The podj''s were unable to be advanced any further.The lantern mentioned in the complaint was not returned for evaluation and therefore, the root cause of initial resistance of these devices could not be determined.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.This report is associated with mfr report numbers: 3005168196-2017-02245, 3005168196-2017-02246.
Event or Problem Description
The patient was undergoing a transjugular intrahepatic portosystemic shunt (tips) procedure to treat a large varices using ruby coils and pod packing coils (podjs).During the procedure, the physician deployed and detached initial ruby coils using a forty-five degree tip lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil and two new podj''s through the same lantern, the physician encountered resistance.Therefore, all three coils were removed and the procedure was completed using a total of about twenty ruby coils and podj''s, the initial lantern and a new lantern.It should be noted that the physician only switched out the lantern during the procedure because he needed a different tip shape.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: 7139244
• Report Number: 3005168196-2017-02244
• Device Sequence Number: 1290381
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 05/17/2025
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F77231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR