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

Catalog Number RBY2C0415

Device Problems Stretched (1601); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil stretch resistant wire (sr wire) was fractured.Conclusion: evaluation of the returned ruby coil revealed that the sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.Fracture of the sr wire will allow the embolization coil to detach.The root cause of the ruby coil getting stuck inside the microcatheter could not be determined.The microcatheter mentioned in the complaint and the pusher assembly to the ruby coil were not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for the lot numbers provided were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-02021.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to detach a ruby coil from its pusher wire.A second ruby coil then became stuck and stretched.The ruby coil was therefore removed, and the procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2017-02022.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the ruby coil getting stuck inside the microcatheter.This report is associated with mfr report number: 3005168196-2017-02021.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7022749
• MDR Text Key: 92737051
• Report Number: 3005168196-2017-02022
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F78317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1