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

Catalog Number RBY2C0530

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-00881.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician deployed and detached the initial ruby coil in the target vessel using a non-penumbra microcatheter without issues.Upon removing the second ruby coil from the dispenser hoop, the scrub technologist noticed that the ruby coil pusher assembly was bent almost perfectly straight up.Therefore, the ruby coil was set aside and the procedure continued using another ruby coil without issues.While attempting to advance a new ruby coil in the target vessel, the physician did not mention difficulty or friction; however, the physician lost access to the gda.Therefore, the physician decided to remove and re-sheath the ruby coil; however, while re-sheathing the ruby coil, resistance was encountered and subsequently, the ruby coil unintentionally detached right at the hub of the microcatheter.The detached coil was then pulled out of the microcatheter and the procedure was completed using three additional ruby coils without issues.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the ruby coil pusher assembly was severely kinked approximately 43.0 cm from the hub, along with multiple other kinks and bends along its length.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned devices confirmed that the first ruby coil pusher assembly was severely kinked.This type of damage can occur when retracting the ruby coil from its packaging hoop at extreme angles or is generally mishandled during removal from the packaging.Further evaluation revealed multiple other kinks and bends along the length of the ruby coil.These damages were likely incidental and occurred during packaging for return to penumbra.Evaluation of the second returned ruby coil confirmed that the embolization coil had been detached with the stretch resistant (sr) wire fractured and the introducer sheath was loaded onto the pusher assembly backwards such that the friction lock was on the distal end.Sr wire fracture is typically a result of forcefully retracting the ruby coil against resistance.The introducer sheath friction lock has a smaller inner diameter (id) than the rest of the introducer sheath.If the introducer sheath is loaded backwards on the pusher assembly and the ruby coil is forcefully retracted through the friction lock, extreme resistance may be experienced and would likely contribute to an sr wire failure.Further evaluation revealed that the pusher assembly had bends in multiple locations.This damage was likely incidental and likely occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint was not returned for further 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.

• 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: 6621843
• MDR Text Key: 76979429
• Report Number: 3005168196-2017-00880
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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: Radiologic Technologist
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F74283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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