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

Catalog Number	RBY2C0420
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.The proximal end of the embolization coil was retracted proximal to the introducer sheath friction lock.Conclusions: evaluation of the returned device revealed that the proximal end of the embolization coil was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the ruby coil mid-joint.If the pusher assembly mid-joint and embolization coil are forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Further evaluation revealed that the embolization coil was detached and the sr wire was fractured.The fracture of the sr wire likely occurred due to forceful retraction of the ruby coil through the introducer sheath friction lock, and allowed the embolization coil to detach.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the distal duodenal artery using ruby coils.During the procedure, after the distal end of a ruby coil exited the tip of the high flow microcatheter, the physician noticed that the coil was unable to take its intended shape and proceeded to ¿run¿ down the vessel.The physician determined that the ruby coil was oversized for the vessel and therefore, re-sheathed and saved the ruby coil on the table for later use.The physician then placed a micro vascular plug in the target vessel and re-attempted to use the same ruby coil; however, the ruby coil would not advance out of its introducer sheath and into the microcatheter.The physician tried rinsing it off in a bowl of saline but the ruby coil would still not advance out of its introducer sheath and into the microcatheter.The microcatheter was then flushed and an attempt was made to unsheath the ruby coil on the back table; however, the ruby coil would still not advance out of its introducer sheath.Therefore, the ruby coil was set aside and the procedure was successfully completed using a smaller sized ruby coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6620484
• Report Number: 3005168196-2017-00867
• Device Sequence Number: 16267202
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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
• Operator of Device: Physician
• Device Expiration Date: 06/27/2024
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F70363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR