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

Catalog Number	RBY4C2060
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 superior mesenteric artery (sma) using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil within the proximal end of a px slim delivery microcatheter (px slim) and, therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly was kinked approximately 23.5 cm, 55.0 cm, 58.5 cm, 61.0 cm, 99.5 cm, 125.0 cm, 131.5 cm and 143.0 cm from the proximal end.The proximal constraint sphere was within the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the proximal constraint sphere.The stretch resistant (sr) wire within the embolization coil was fractured.Minor offset coil winds were present along the length of the embolization coil.Conclusions: evaluation of the returned ruby coil revealed a fractured stretch resistant (sr) wire.This type of damage typically occurs while forcefully retracting the device against resistance.The complaint reported that resistance was encountered while advancing the ruby coil within the proximal end of the px slim.This may have contributed to the sr wire becoming fractured.The px slim was not returned for evaluation and the ruby coil had a fractured sr wire and could not be functionally tested; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation revealed kinks along the pusher assembly.These kinks may be incidental to the reported complaint 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: 8537749
• Report Number: 3005168196-2019-00769
• Device Sequence Number: 367721
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/24/2019
• 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: 06/25/2025
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F77905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/24/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005