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

Catalog Number RBY4C0305

Device Problems Bent (1059); Material Too Rigid or Stiff (1544); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2018

Event Type  malfunction  

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 product was not returned for 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: 3005168196-2018-01127, 3005168196-2018-01129.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils, pod4s, and pod packing coils (podjs).During the procedure, the physician felt resistance while advancing a pod4 within the proximal end of a non-penumbra microcatheter and, therefore, the pod4 was removed.The physician then felt resistance while advancing a ruby coil and, consequently, the pusher assembly became bent.The ruby coil was therefore removed.The physician then felt resistance while advancing a podj out of the distal tip of the microcatheter and, therefore the podj was removed.The procedure was completed using the same microcatheter and new ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7579495
• MDR Text Key: 110463761
• Report Number: 3005168196-2018-01128
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F74935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR