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

Catalog Number RBY4C1240

Device Problems Electrical Overstress (2924); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

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 renal artery using ruby coils.During the procedure, the physician successfully deployed and detached three ruby coils using a px slim delivery microcatheter (px slim).Another ruby coil then became stuck within the px slim, and therefore the px slim was removed with the ruby coil inside.The procedure then ended at this point because the existing coil mass was sufficient.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 in multiple locations.The embolization coil was detached from its pusher assembly with the proximal constraint sphere intact, inside its introducer sheath with offset coil winds.Conclusions: evaluation of the returned device revealed that the ruby coil embolization coil was detached from its pusher assembly and stuck inside it introducer sheath with offset coil winds.This damage likely occurred due to forceful retraction against resistance, which may have caused the distal section of the pusher assembly to elongate beyond the reach of the pull wire, which would result in the embolization coil detaching from the pusher assembly.The root cause of the initial resistance and the embolization coil getting stuck within the px slim could not be determined.Further evaluation of the returned device revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and likely occurred while packaging the device for return to penumbra.The embolization coil was detached from its pusher assembly and, therefore, the returned ruby coil could not be functionally tested for the reported issue.The px slim referred to in the complaint was not returned for to penumbra for evaluation.Penumbra coils and catheters 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: 7332441
• MDR Text Key: 102225875
• Report Number: 3005168196-2018-00542
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,02/13/2018

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 Expiration Date: 12/31/2019
• Device Catalogue Number: RBY4C1240
• Device Lot Number: F61798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• 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: 02/13/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 05/02/2018
• Supplement Dates FDA Received: 05/02/2018; 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR