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

Catalog Number RBYPODJ45

Device Problems Bent (1059); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 number: 3005168196-2016-01894.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (podj coils).During the procedure, while advancing a podj coil through a lantern delivery microcatheter (lantern), the physician applied force and was able to partially advance the coil out of the lantern.However, resistance was encountered and the podj coil pusher assembly became slightly bent.Therefore, the physician removed the podj coil and opened a new podj coil for use in a more proximal location.Again, the physician used force to partially advance the coil out of the lantern.However, the same resistance was encountered and the pusher assembly also became slightly bent.Therefore, the podj coil and lantern were removed and the procedure was completed using a new lantern and a new ruby coil.It should be noted that the first lantern was not reinserted into the patient because it was not long enough for the patient's anatomy.It should also be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.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: 6213887
• MDR Text Key: 63626033
• Report Number: 3005168196-2016-01893
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• 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: 12/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F70734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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: 21 YR
• Patient Weight: 68