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

Catalog Number RBY4C2060

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil¿s embolization coil was detached from the pusher assembly and the proximal constraint sphere was intact.Conclusions: evaluation of the returned devices revealed that the first ruby coil could not be advanced out of the introducer sheath due to compression and offset coil winds on the embolization coil.This damage likely occurred due to forceful advancement of the ruby coil against resistance.Further evaluation revealed that the second ruby coil was detached and the stretch resistant (sr) wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance.The resistance experienced may have occurred due to not fully opening the rotating hemostasis valve (rhv) prior to withdrawal.Advancing the ruby coils directly through a 5f sheath likely contributed to the resistance experienced while advancing.The ruby coil instructions for use states that ¿ruby coils are compatible with penumbra microcatheters with a minimum inner lumen of 0.025inch¿.If a catheter with a larger lumen is used to deliver a ruby coil, difficulty may be experienced.The second ruby coil¿s pusher assembly, as well as the 5f non-penumbra sheath and lantern mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2017-01219.

Event Description

The patient was undergoing a coil embolization procedure to treat a venous aneurysm using ruby coils.During the procedure, the physician deployed and detached an initial ruby coil using only a non-penumbra sheath without any issues.While attempting to deploy a new ruby coil into the aneurysm, the physician met resistance with the previously placed coil.The ruby coil was then removed and put in a bowl of saline but it would not resheath entirely and was not redeployed.Next, while attempting to deploy a new ruby coil into the aneurysm, the physician encountered resistance again and attempted to resheath the coil.However, while the ruby coil was being retracted back through the sheath, it unintentionally detached.Therefore, the physician removed the rotating hemostasis valve (rhv) and pulled the entire ruby coil out of the sheath.The procedure was then successfully completed using a lantern delivery microcatheter (lantern), six additional ruby coils and one pod packing coil (podj).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: 6729065
• MDR Text Key: 80652722
• Report Number: 3005168196-2017-01220
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• 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: 06/21/2017

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: RBY4C2060
• Device Lot Number: F74239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• 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: 24 YR