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

Catalog Number	RBY2C0305
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal mammary arteries (rima) using ruby coils.During the procedure, the physician placed the initial coils in the target vessel using a lantern delivery microcatheter (lantern).After placing the last ruby coil, the lantern was removed and the final angiography showed that the ruby coil was unraveling out of the rima; therefore, the physician used a snare device to successfully remove the ruby coil.The physician then attempted to pack the proximal portion of the rima with a pod packing coil (podj) using the same lantern; however, the podj was oversized and was therefore, removed intact.The procedure ended at this point and no additional coil was placed to pack the proximal cap of the rima.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: 9112584
• Report Number: 3005168196-2019-01812
• Device Sequence Number: 16589904
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 08/29/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: RBY2C0305
• Device Lot Number: C00455
• Was Device Available for Evaluation?: No
• 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: 08/29/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Date Report Sent to FDA: 01/01/2005