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

Catalog Number	RBY4C1650
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	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 27.0, 69.0, 99.0, and 142.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the proximal constraint sphere was present inside the distal detachment tip (ddt).The pull wire was advanced distal to the ddt.The introducer sheath was ovalized approximately 46.0 cm from the proximal end.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil sr wire was fractured.This type of damage typically occurs due to forceful retraction against resistance.Further evaluation revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred during the packaging of the catheter for return to penumbra.Evaluation of the returned lantern revealed that the distal tip of the catheter shaft was ovalized.Further evaluation of the returned lantern revealed that the catheter shaft was kinked in multiple locations.The reported complaint stated the subject coil was the last coil delivered during the procedure; therefore, it is unclear when the catheter became damaged.If these damages were present during the procedure, they may have contributed to the resistance experienced while advancing the subject ruby coil.It is possible some of these damages were incidental to the reported complaint and may have occurred post-procedure.Penumbra coils and catheters 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 number: 3005168196-2018-02473.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed a ruby coil in the target vessel using the lantern.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and decided to retract the ruby coil for repositioning.However, upon retraction and redeployment, the ruby coil got "hung up" and subsequently, unintentionally detached with approximately half of the ruby coil in the lantern and the other half in the aneurysm sac.Therefore, the physician removed the lantern containing the detached coil.The physician then performed a scan and noticed that the aneurysm was completely filled and no additional coil was needed.The procedure was ended at that point.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: 8186482
• Report Number: 3005168196-2018-02472
• Device Sequence Number: 2792007
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/20/2018
• 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: 07/18/2026
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F84771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 87
• Date Report Sent to FDA: 01/01/2005