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

Catalog Number RBYLP0304

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps and a lantern delivery microcatheter (lantern).During the procedure, after advancing a ruby coil lp into the target location, the physician decided to reposition the lantern.Therefore, the ruby coil lp was removed out from the microcatheter.Subsequently, while retracing the coil back into the introducer sheath, the physician experienced resistance and, consequently, the ruby coil lp had detached from the pusher assembly.The physician then advanced a new ruby coil lp to the target location; however, the physician decided to remove the ruby coil lp to reposition the lantern.While retracting the ruby coil lp through the lantern, the physician experienced resistance and the ruby coil lp unintentionally detached inside the lantern.The procedure was completed using additional ruby coil lps and a new lantern.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Evaluation of the returned ruby coil lp confirmed that the embolization coil was detached.Further evaluation of the device revealed kinks on the pusher assembly this damage typically occurs due to advancement against resistance.Based on the reported complaint, the ruby lp was advanced through a lantern microcatheter.The lantern microcatheter inner diameter (id) is larger than intended for advancement of the ruby coil lp and likely caused the resistance experienced during the procedure.If the ruby coil lp is retracted against resistance, the embolization coil may detach.The detached embolization coil was not returned for evaluation.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 LP
• 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: 15565392
• MDR Text Key: 303402452
• Report Number: 3005168196-2022-00462
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021778
• UDI-Public: 815948021778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYLP0304
• Device Lot Number: F99157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2020
• 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: 76 YR
• Patient Sex: Male