MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number RBYPOD5

Device Problems Kinked (1339); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly for the pod5.The pusher assembly was kinked approximately 10.5, 15.5, and 74.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned pod5 confirmed that the pusher assembly was kinked.This type of damage was likely a result of mishandling during retraction as reported in the complaint.Further evaluation of the returned device revealed that the embolization coil had offset coil winds.This damage was likely incidental to the reported issue and likely occurred due to packaging the device for returned to penumbra without the embolization coil being protected.Evaluation of the returned podj revealed that the distal tip of the introducer sheath had coagulated blood inside.While attempting to advance the podj within its introducer sheath, resistance was encountered and the device could not be advanced out of its sheath or through a demonstration microcatheter for the reported issue.The root cause of the reported issue could not be determined.Evaluation of the returned ruby coil revealed it was kinked along its length and stuck inside the lantern.These damages were likely incidental to the reported failure and occurred post-procedure.The ruby coil¿s reported inability to advance out of the returned lantern was likely due to the lantern¿s distal ovalization.Evaluation of the lantern revealed an ovalization on its distal tip.This damage may have been due to forcefully manipulating the device within patient anatomy or during preparation for the procedure.This ovalization likely contributed to the ruby coil¿s inability to advance out the lantern¿s distal tip.Further evaluation revealed the ruby coil was stuck inside the returned lantern.This is likely incidental and occurred as a result of the devices being removed from the patient together and packaged for return to penumbra.Evaluation of the returned ruby coil revealed no visible damage.It was reported that the device was removed due to a sizing issue.Evaluation of the returned ruby coil pusher assemblies revealed that the pet locks were broken and the embolization coils were detached.There was no reported functional issue for the returned devices.It was reported that the pusher assemblies belongs to two successful detached devices.Further evaluation of the revealed that the pusher assembly was fractured.This damage was likely incidental and may have occurred while packaging the devices for return.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.This report is associated with mfr report numbers: 3005168196-2018-00922, 3005168196-2018-00923, 3005168196-2018-00924.

Event Description

The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using a pod5, a pod packing coil (podj), ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to deploy a pod5 into the target vessel using the lantern, the physician determined that the pod5 was oversized and decided to retract it; however, during the retraction, the pod5 became kinked.The physician then opened a podj and attempted to advance it through the lantern; however, the podj kicked the lantern out of the aneurysm and therefore, the podj was removed.The physician then smoothly advanced a ruby coil within the lantern until the last one centimeter from the distal tip of the lantern and the physician thought that there may be a kink in the lantern; therefore, the lantern and ruby coil were removed.Upon removal, the lantern was confirmed to be kinked.The procedure was completed using other coils, the same diagnostic catheter, a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: POD5
• 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: 7485436
• MDR Text Key: 107321597
• Report Number: 3005168196-2018-00921
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F79789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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: 25 YR