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

Model Number RBY4C0415-B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

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 left internal iliac artery using a ruby coil and a lantern delivery microcatheter (lantern).It was noted that the patient anatomy was tortuous and calcified.During the procedure, the physician experienced resistance while advancing a ruby coil within its introducer sheath; therefore, the ruby coil and lantern were removed.Afterwards, the physician advanced the ruby coil through the lantern several times on the back table and subsequently, the pusher assembly of the ruby coil broke, and the ruby coil detached within the lantern.Therefore, the physician flushed the ruby coil out of the lantern.The procedure was completed using another ruby coil, two 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 damaged on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 80.0 cm, 81.0 cm, 84.0 cm, and 86.0 cm from the proximal end.The pusher assembly was fractured approximately 79.0 cm, 88.0 cm, and 174.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.The embolization coil was not returned for evaluation.Conclusions: evaluation of the returned ruby coil pusher assembly confirmed a fracture and revealed kinks near the fractured location.If the device is forcefully advanced against resistance, damages such as pusher assembly kinks and subsequently fracture may occur.If the pusher assembly is fractured, and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed a damaged pet lock, and additional pusher assembly fractures.This damage was likely incidental to the complaint.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: 10521411
• MDR Text Key: 207375147
• Report Number: 3005168196-2020-01438
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 00814548018348
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/18/2020

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: RBY4C0415-B
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F98321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• 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: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1