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

Catalog Number RBYPODJ60

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-00650, 3005168196-2017-00652.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (podj coils) and lantern delivery microcatheters (lantern).During the procedure, the physician successfully deployed and detached a pod5 coil in the target vessel using a lantern delivery microcatheter (lantern).While attempting to place a podj coil in the outflow behind the pod5, the physician experienced resistance while advancing the podj coil through the lantern and subsequently, the podj coil buckled the system out of the outflow.Therefore, the physician decided to re-sheath the podj coil.However, upon retraction the podj coil unintentionally detached inside the lantern; the physician then removed the lantern with the detached coil inside.It was reported that the strain relief wire unraveled as the podj coil was being removed from the lantern.The lantern was set aside and the physician opened a new lantern to continue the procedure.While attempting to load a ruby coil into the lantern, the scrub technologist kept experiencing resistance and therefore, the ruby coil was re-sheathed and removed.The scrub technologist then attempted to advance the same ruby coil out of its introducer sheath on the back table; however, the ruby coil unintentionally detached from the pusher assembly.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• 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: 6520751
• MDR Text Key: 74010127
• Report Number: 3005168196-2017-00651
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F71381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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: 36 YR