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

Catalog Number RBY2C0725

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure to treat a dialysis fistula in the ulnar vein using ruby coils.During the procedure, a ruby coil pusher assembly became kinked and subsequently, resistance was met upon advancing the ruby coil into the non-penumbra microcatheter.Therefore, the ruby coil was removed and the procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the ruby coil pusher assembly was kinked in multiple locations along its length, including approximately 77.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device confirmed that the pusher assembly was kinked.This damage may have occurred due to forceful handling of the ruby coil during advancement into a microcatheter.The kinks prevented the ruby coil from being re-sheathed into a demonstration introducer sheath during functional analysis, and likely contributed to the resistance experienced while advancing into the microcatheter.The ruby coil introducer sheath and the non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being updated on this follow-up #2 mfr report: box 1.Title; box 3.Occupation; box 3.Other occupation (description).

• 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: 7146185
• MDR Text Key: 95926240
• Report Number: 3005168196-2017-02264
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

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
• Device Operator: Physician
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F73108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 12/27/2017
• Supplement Dates FDA Received: 01/24/2018; 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2016
• 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: 45 YR
• Patient Weight: 66