MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C2860
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional 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.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery for an arteriovenous malformation (avm) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician advanced a px slim delivery microcatheter (px slim) towards a sac in the right pulmonary avm and then deployed and detached ten pc400 coils into the patient.While attempting to advance the eleventh pc400 coil through the px slim, the physician had difficulty after the coil was advanced approximately half way through the px slim.Therefore, the physician removed the px slim containing the pc400 coil from the patient's body.While the devices were outside of the patient, the physician confirmed that there were no visual damages to the px slim and attempted to advance the pc400 coil through the px slim but was still unable to.The physician then attempted to advance a new pc400 coil through the same px slim while still outside of the patient's body and found that the coil advanced through successfully.Therefore, the physician adjusted the px slim to decrease deflexion, flushed its inner lumen and then checked it again for kinks.The px slim was reinserted into the patient and the procedure was successfully completed using a new pc400 coil and the same px slim.As a result of the procedure, the patient's blood flow was almost decreased.It should be noted that the patient had some tortuous vessels and that the physician did not use force to manipulate the px slim through the patient's anatomy.In addition, the physician flushed the px slim after delivering each pc400 coil.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5810422
• Report Number: 3005168196-2016-01032
• Device Sequence Number: 625920
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 00814548011981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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
• Operator of Device: Physician
• Device Expiration Date: 03/15/2024
• Device Catalogue Number: 4002C2860
• Device Lot Number: F68511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2016
• Initial Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR