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

Catalog Number RBYPODJ60

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2017-00417, 3005168196-2017-00419, 3005168196-2017-00420, 3005168196-2017-00457.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization in the external and internal iliac artery using ruby coils and pod packing coils (podj coils).During the procedure, the physician advanced two ruby coils in the target vessel using a lantern delivery microcatheter (lantern); however, due to a very high flow in the internal iliac artery, both ruby coils would not take their intended shape and anchor in the aneurysm.After several failed attempts, the ruby coils were removed and a pod8 coil was successfully deployed and detached in the aneurysm.The scrub technologist then inadvertently bent both ruby coils pusher assemblies while attempting to re-sheath them.Next, the scrub technologist inadvertently pulled off the introducer sheath of podj coil after removing it from the packaging hoop.While attempting to re-sheath it, the podj coil pusher assembly was accidentally broken; therefore, the podj coil was set aside.The physician then opened a new podj coil and attempted to advance it through the lantern; however, resistance was experienced prior to the coil exiting the lantern and the physician decided to retract it.Upon retraction, the podj coil unintentionally detached from the pusher assembly and unraveled inside the lantern.The lantern was then pulled out of the other manufacturer¿s 5f catheter with the detached coil still inside.It was reported that the technician dropped the first lantern; therefore, it was not used for the remainder of the procedure.The procedure was completed using another lantern and additional ruby coils.In addition, there was no alleged deficiency with the first 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: 6424662
• MDR Text Key: 70704830
• Report Number: 3005168196-2017-00418
• 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: Physician
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RBYPODJ60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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