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

Catalog Number RBY4C2060

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Results: dried blood was observed on the ruby coil.The ruby coil was kinked approximately 115.0 cm from the proximal end.Conclusions: evaluation of the returned devices revealed that blood was on both ruby coils with lot #f77349 and #f75630.Ruby coil with lot #f77349 had a deformed introducer sheath and compressed embolization coil.Since both devices were reported as not being used in the procedure, the root cause of the observed blood and damages could not be determined.Further evaluation revealed that both pusher assemblies were kinked.These damages may have occurred due to forceful handling of the ruby coils during preparation or use.Further evaluation revealed that the pusher assembly of ruby coil with lot #f75268 was kinked.This damage may have occurred due to forceful manipulation of the ruby coil against resistance.The kink that was reportedly observed near the distal tip of the lantern delivery microcatheter (lantern) likely contributed to the inability to advance the ruby coil.Further evaluation revealed the introducer sheath was damaged in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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 numbers: 3005168196-2017-01586; 3005168196-2017-01587; 3005168196-2017-01589.

Event Description

The patient was undergoing a coil embolization procedure in the abdominal aorta using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed the lantern into the patient, then successfully deployed and detached ruby coils.The physician did not mention any resistance while placing the lantern.It was reported that one ruby coil (lot #f77349) dropped on the floor and was not used.In addition, while removing another ruby coil (lot #f75630) from its dispenser hoop, the hospital staff inadvertently bent the pusher assembly.Subsequently, this ruby coil was not used for the procedure.Finally, while attempting to advance another ruby coil (lot #f75268) through the lantern, the physician was unable to advance the coil pass the distal tip of the lantern and decided to remove the devices.Upon retrieval, the ruby coil pusher assembly was found to be bent and a kink was observed three centimeters from the distal tip of the lantern.Therefore, the procedure was successfully completed using a new lantern and additional ruby coils.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: 6881101
• MDR Text Key: 88246044
• Report Number: 3005168196-2017-01588
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F75630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• 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