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

Model Number	RBY2C2860-B
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
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: 3005168196-2020-01755, 3005168196-2020-01756, 3005168196-2020-01757, 3005168196-2020-01758, 3005168196-2020-01759, 3005168196-2020-01761, 3005168196-2020-01762, 3005168196-2020-01763, 3005168196-2020-01764, 3005168196-2020-01765.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using ruby coils, pod packing coils (pod pcs), pod coils, ruby coil detachment handles (handles) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced five ruby coils, two pod pcs, and two pod coils into the target vessel using the lantern and attempted to detach them using two different handles; however, the ruby coils, pod pcs and pod coils failed to detach.Therefore, the physician manually detached the five ruby coils, two pod pcs and two pod coils.The procedure ended at this point.There was no report of an adverse effect to this patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10690801
• Report Number: 3005168196-2020-01760
• Device Sequence Number: 3934001
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 00814548019314
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020
• 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 Model Number: RBY2C2860-B
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F95946
• 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: 09/22/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 79
• Date Report Sent to FDA: 01/01/2005