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

Catalog Number RBY2C2457

Device Problems Kinked (1339); Failure to Advance (2524); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

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: 3005168196-2018-00059.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils.During the procedure, the physician attempted to place a ruby coil into the target location using a lantern delivery microcatheter (lantern), however the ruby coil was the wrong size.The ruby coil was therefore removed, re-sheathed, and set on the back table.When attempting to re-advance the ruby coil after placing three other coils, the physician then was unable to advance the ruby coil out of its introducer sheath, and therefore the ruby coil was not used.Another ruby coil was accidentally kinked during handling, and therefore the physician was unable to advance the ruby coil out of its introducer sheath and into the lantern.The procedure was completed using the same lantern and additional ruby coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the first ruby coil¿s pusher assembly was kinked approximately 93.0 cm from the proximal end.The pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The distal detachment tip (ddt) was fractured off the pusher assembly within the introducer sheath , and the embolization coil was detached.Conclusions: evaluation of the first ruby coil revealed the pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath,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the introducer sheath to properly seat on the pusher assembly midjoint.If the pusher assembly midjoint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.The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 kinked likely occurred due to forceful advancement against this resistance.Further evaluation revealed the ddt was fractured off, the embolization coil was detached, this damage was likely incidental and may have occurred during handling of the ruby coil after it was removed from the procedure.Evaluation of the second ruby coil revealed the pusher assembly was kinked.This damage likely occurred due to forceful handling during preparation for use, and likely contributed to the inability to advance the ruby coil into the lantern.The lantern mentioned in the complaint was 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 numbers: 3005168196-2018-00059.

• 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: 7169119
• MDR Text Key: 96724349
• Report Number: 3005168196-2018-00058
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C2457
• Device Lot Number: C03242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• 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: 70 YR