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

Catalog Number RBYPODJ60

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00869.

Event Description

The patient was undergoing a coil embolization procedure to treat an endoleak using a pod packing coil (podj).During the procedure, the physician advanced a lantern delivery microcatheter (lantern) in the endoleak using a needle and placed a ruby coil in the target vessel.While attempting to advance a podj through the lantern, the podj became stuck inside the lantern and could not be pushed forward; therefore, the lantern and podj were removed together.The procedure was completed using a non-adhesive liquid embolic agent and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly and an unknown material was on the pusher assembly.The pusher assembly was kinked approximately 82.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned podj revealed that the device could be advanced through a microcatheter.During the functional test, the podj was advanced through a demonstration microcatheter and out of the distal tip without an issue.The root cause of the podj getting stuck inside the microcatheter during the procedure could not be determined.The foreign material found on the podj pusher assembly could not be identified.The lantern identified in the complaint was not returned to penumbra for evaluation.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.

• Brand Name: POD PACKING 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: 7466319
• MDR Text Key: 106719925
• Report Number: 3005168196-2018-00868
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K170852
• 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,Followup
• Report Date: 01/01/2005,03/27/2018

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: RBYPODJ60
• Device Lot Number: F81316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• 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
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2018
• 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: 28 YR