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

Catalog Number RBY4C0620-A

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure for a gastrointestinal (gi) bleed using ruby coils.During the procedure, while attempting to reposition the last ruby coil into the target vessel, the physician was advancing and retracting the coil, then realized that the coil had unintentionally detached inside the patient.Therefore, the physician required a snare device to remove the detached ruby coil from the celiac artery and the aorta.Subsequently, approximately ninety percent of the coil was removed and approximately three centimeters of residual coil remained in the common hepatic artery.It was reported that the remaining residual coil was likely of no clinical significance to the patient.The procedure ended at this point with no additional coils placed.There was no report of an adverse effect to the patient.Following the procedure, the patient did well.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the stretch resistant wire (sr wire) was fractured and the embolization coil was detached from the pusher assembly.The proximal constraint sphere was inside the distal detachment tip (ddt).The introducer sheath was loaded incorrectly on the pusher assembly.Conclusions: evaluation of the returned device revealed that the ruby coil¿s sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the ruby coil is forcefully retracted during repositioning against resistance, damage such as this may occur.The introducer sheath loaded incorrectly on the pusher assembly was likely incidental and may have occurred during packaging of the device for return.All 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5798305
• MDR Text Key: 49658757
• Report Number: 3005168196-2016-00994
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• 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,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: RBY4C0620-A
• Device Lot Number: F63040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 86 YR