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

Catalog Number	RBY2C0320
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
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 to treat a ruptured aneurysm in the superior mesenteric artery (sma) using ruby coils.It was noted that the patient had a very acute bend towards the sma.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and the ruby coil would not advance.Subsequently, the ruby coil pusher assembly kinked and therefore, the ruby coil was removed.The procedure was completed using another coil and the same microcatheter.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 51.0 cm, 52.0 cm and 54.0 cm from the proximal end.The embolization coil was intact with the distal detachment tip (ddt) of the pusher assembly.The embolization coil had minor offset coil winds throughout the coil.The introducer sheath was undamaged.Conclusions: evaluation of the returned ruby coil confirmed kinks along the pusher assembly.It was reported that resistance was encountered while attempting to advance the ruby coil through a non-penumbra microcatheter.If the device is forcefully advanced against resistance, damage such as kinks may occur.During functional testing, the device was unable to be re-sheathed due to kinks in the pusher assembly.The root cause of the initial resistance was unable to be determined.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.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: 8294406
• Report Number: 3005168196-2019-00165
• Device Sequence Number: 16483119
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 01/03/2019
• 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: 08/02/2025
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F78485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005