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

Model Number RBY4C0315-B

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

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 lumbar artery using ruby coils and non-penumbra microcatheter.During the procedure, the physician experienced resistance while advancing the ruby coil through the rotating hemostasis valve (rhv).Therefore, the physician decided to retract the ruby coil.It was also reported that flushing did not solve the issue.Subsequently, while attempting to advance the same ruby coil, the pusher assembly became broken.Therefore, the ruby coil was removed.The procedure was completed using another coil and the same microcatheter.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 pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds near its distal end.Conclusions: evaluation of the returned ruby coil revealed a kink on its pusher assembly and offset coil winds on the embolization coil.If the device is forcefully advanced against resistance, damages such as these may occur.The non-penumbra microcatheter and rhv used in the procedure were not returned for evaluation.Therefore, the root cause of the resistance experienced during the procedure was unable to be determined.During functional testing, the returned ruby coil was able to advance through a demonstration rhv and a lantern without issue.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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10172004
• MDR Text Key: 195714814
• Report Number: 3005168196-2020-00783
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/26/2020

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: Health Professional
• Device Model Number: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F85749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1