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

Model Number	RH1-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
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 number: 3005168196-2021-00458.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using pod packing coils (pod pcs), a ruby coil detachment handle (handle), a lantern delivery microcatheter (lantern), and a non-penumbra guide catheter.During the procedure, the physician successfully implanted two ruby coils and five pod pcs using a re-sterilized handle.After advancing the same the handle over the proximal end of a pod pc pusher assembly, resistance was encountered.Therefore, the handle was removed.It was reported that the handle had been used in another case and re-sterilized before use in this case.The physician attempted to use a new handle to detach the pod pc but was unsuccessful.While attempting to retract the pod pc, the pusher assembly broke at the hub of the microcatheter.The physician used forceps and a needle to remove the broken pusher assembly from the microcatheter.Upon removal, the coil detached.Fluoroscopy revealed that the last three centimeters of the pod pc remained inside the distal tip of the microcatheter.Therefore, a guidewire was used to implant the pod pc into the target location.At this point, the procedure was ended.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11445719
• Report Number: 3005168196-2021-00459
• Device Sequence Number: 3497153
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• 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: 03/23/2023
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F97042
• 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: 02/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005