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

Catalog Number RBY4C0860

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the second ruby coil evaluated.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was inside the distal detachment tip (ddt).The embolization was detached from its pusher assembly and inside its introducer sheath.Conclusions: evaluation of the first returned ruby coil revealed that the pusher assembly was fractured.This type of likely occurred from the pusher assembly being accidentally kinked as mentioned in the complaint.Then further manipulation of the kinked pusher likely resulted in the pusher assembly fracturing as the kink was straightened.Further evaluation of the returned device revealed that the embolization coil was detached from its pusher assembly.The separation of the two fractured pusher assembly segments allowed the pull wire to be retracted out of its ddt caused the embolization coil to detach.Evaluation of the second returned ruby coil revealed that its pusher assemblies was kinked.This damage was likely accidental as mentioned in the complaint.Further evaluation revealed that the sr wire was fractured and the proximal constraint sphere was inside the distal detachment tip (ddt).This type of damage likely occurred due to forceful retraction against resistance, while re-sheathing the embolization coil as it was returned halfway re-sheathed inside its introducer sheath.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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.This report is associated with mfr report number: 3005168196-2017-02195.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician successfully deployed and detached two ruby coils into the target vessel.However, while attempting to advance two new ruby coils through a non-penumbra microcatheter, the scrub technologist inadvertently bent the back end of the ruby coils; therefore, both ruby coils were removed.The procedure was then completed using a new ruby coil and the same microcatheter.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: 7113706
• MDR Text Key: 95615081
• Report Number: 3005168196-2017-02194
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F77378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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: 74 YR