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

Model Number	RBY4C2060-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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: 3005168196-2021-00540, 3005168196-2021-00542.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, a pod packing coil (pod pc), and a non-penumbra microcatheter.During the procedure, two ruby coils and a pod pc were re-sheathed and saved for later use, as initially the two ruby coils and the pod pc were too long for the branch vessel.Later, while attempting to use the two previously removed ruby coils, the physician noticed that the two ruby coils were stuck within its introducer sheaths and would not advance at all.Therefore, the two ruby coils were removed.Subsequently, while the physician attempted to advance the previously removed pod pc within its introducer sheath, the physician experienced resistance.Subsequently, the physician kinked the pusher assembly of the pod pc.Therefore, the pod pc was removed.The procedure was completed using new ruby coils and the same microcatheter.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: 11532280
• Report Number: 3005168196-2021-00541
• Device Sequence Number: 3764749
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 02/23/2021
• 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: 04/12/2025
• Device Model Number: RBY4C2060-A
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F75630
• 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: 02/23/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005