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

Catalog Number RBY4C0860

Device Problems Bent (1059); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the embolization coil was intact with the ruby coil pusher assembly.There was clotted blood present on the embolization coil.The distal portion of the embolization coil had several offset coil winds.The pusher assembly was kinked approximately 104.0 and 116.0 cm from the proximal end.During functional analysis, the ruby coil was advanced out of its introducer sheath with some difficulty after being flushed with cavicide solution.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil had multiple offset coil windings and the pusher assembly was kinked.If an rhv is not used in the procedure, the introducer sheath may not maintain proper alignment, and resistance may be experienced.The damage observed on the embolization coil can occur if the introducer sheath is not properly aligned inside of the hub of the microcatheter during advancement of the ruby coil.Continued attempts to manipulate the coil can further damage the embolization coil and may contribute to any resistance experienced during the procedure.The pusher assembly kinks were likely a result of continued attempts to advance the embolization coil against resistance.The clotted blood present on the embolization coil is likely a result of not maintaining continuous flush throughout the procedure.The non-penumbra microcatheter mentioned in the complaint and pod8 were 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.This report is associated with mfr report number: 3005168196-2017-01239.

Event Description

The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils and pod8''s.During the procedure, the physician successfully deployed and detached initial penumbra coils into the target vessel using a non-penumbra microcatheter.While attempting to advance a new ruby coil through the microcatheter, the physician experienced resistance and subsequently, the ruby coil pusher assembly became bent.Therefore, the ruby coil was removed and it was observed that the microcatheter appeared to be bent.The physician then deployed and detached additional penumbra coils into the target vessel using the same microcatheter.While attempting to pull a new pod8 out of its packaging hoop, the physician inadvertently bent the pod8 pusher assembly.Therefore, the pod8 was set aside and the procedure was successfully completed using four ruby coils, two pod packing coils (podj''s), one pod6 and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 6745787
• MDR Text Key: 81143613
• Report Number: 3005168196-2017-01238
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• 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
• Report Date: 06/28/2017

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
• Device Operator: Physician
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F75497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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: 64 YR