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

Model Number RBY2C3260-A

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.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 splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed three ruby coils into the target vessel using the lantern.While attempting to insert the fourth ruby coil into the lantern, the pusher assembly of the ruby coil seemed stuck.The physician attempted multiple times to advance and retract the ruby coil through its introducer sheath; however, the ruby coil only advanced a few centimeters into the lantern before the pusher assembly became stuck.Therefore, the ruby coil was removed and afterwards, it was noticed that the connection between the ruby coil and its pusher assembly was broken.The procedure was completed using additional ruby coils, pod packing coils (pod pcs) and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The distal detachment tip (ddt) was fractured off the distal tip of the pusher assembly.The embolization coil was detached from the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed the distal detachment tip was fractured off the pusher assembly.Due to this damage, the returned device was unable to be functionally tested for the reported event.If the rhv is overtightened, it may contribute to resistance while attempting to advance the coil and subsequent resistance and fracture of the pusher assembly upon retraction.Further evaluation revealed minor offset coil winds in the embolization coil.This damage is incidental and likely occurred due to being returned outside of its protective introducer sheath.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.Penumbra coils are visually 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
• MDR Report Key: 10834543
• MDR Text Key: 216087365
• Report Number: 3005168196-2020-01980
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBY2C3260-A
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F98147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR