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

Catalog Number	RBY2C0520
Medical Device Problem Codes	Failure to Fold (1255); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-01307; 3005168196-2018-01308; 3005168196-2018-01310; 3005168196-2018-01311; 3005168196-2018-01312.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the accessory renal artery and the inferior mesenteric artery (ima) using ruby coils and a pod6.During the procedure, the physician successfully placed the initial two coils in the accessory renal artery using a non-penumbra artery.While attempting to advance a ruby coil through the microcatheter, the hospital technologist experienced resistance and bent the ruby coil pusher assembly twice; therefore, it was removed.While attempting to place a new ruby coil in the ima, the ruby coil would not take its intended shape; therefore, it was removed.While attempting to re-sheath the ruby coil, the hospital technologist pulled the ruby coil passed the friction lock and the embolization coil was coming out of the proximal end of the introducer sheath.The physician then advanced a new ruby coil in the ima; however, the ruby coil did not take its intended shape and therefore, was removed.It was reported the ruby coil pusher assembly was kinked.Next, the physician advanced two other ruby coils in the ima, but the ruby coils did not take their intended shape; therefore, they were removed.While advancing a pod6 into the ima, there was some tension and the microcatheter and guide catheter came out the ima and into the aorta.It was reported that approximately 30 centimeters of the pod6 was still in the microcatheter and could not be advanced into the ima.Subsequently, the pod6 unintentionally detached.Therefore, the physician used a snare device to push the remaining pod6 out of the microcatheter and guide catheter, and removed the microcatheter and guide catheter from the patient¿s body.The physician then used the snare device to remove the detached pod6 from the patient¿s body.The physician then decided to stop the procedure after removal of the pod6 and did not treat the ima.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: 7659414
• Report Number: 3005168196-2018-01309
• Device Sequence Number: 2012625
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/04/2018

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: 01/07/2025
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F73592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR