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

Catalog Number RBY2C2860

Device Problems Positioning Failure (1158); Failure to Advance (2524); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 in the thoracic artery using ruby coils.During the procedure, after introducing the introducer sheath of a ruby coil through the hub of a lantern delivery microcatheter (lantern), the physician asked his fellow physician to hold the introducer sheath and the lantern together.After advancing about five centimeter of the ruby coil into the lantern, the fellow physician inadvertently pulled the ruby coil introducer sheath back and the ruby coil began to form outside the lantern; therefore, the physician decided to re-sheath the ruby coil.While re-sheathing the ruby coil, the physician pulled the ruby coil pusher assembly pass the friction lock of the introducer sheath and the ruby coil began to come out the proximal end of the introducer sheath; therefore, the physician removed the entire introducer sheath and successfully re-sheathed the ruby coil from the pusher assembly.After that, the physician loaded the ruby coil introducer sheath into the hub of the lantern and attempted to re-advance the ruby coil into the lantern; however, the ruby coil would not advance out of its introducer sheath and into the lantern.Therefore, the ruby coil was removed and the procedure was completed using four additional ruby coils and the same lantern.It was reported that the physician did not wipe down or rinse off the ruby coil prior to re-sheathing it.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Evaluation of the returned ruby coil revealed the pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly midjoint.If the pusher assembly midjoint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.The pusher assembly mid-joint being retracted proximal to the introducer sheath friction lock likely prevented the ruby coil from being advanced into the lantern during the procedure.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.

• 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: 6883659
• MDR Text Key: 86936880
• Report Number: 3005168196-2017-01603
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• 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: 08/24/2017

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: RBY2C2860
• Device Lot Number: F76939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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