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

Catalog Number	4004C1030
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
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.This report is associated with mfr report number: 3005168196-2018-01812; 3005168196-2018-01813.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coils 400 and a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance a smart coil through a px slim, the physician experienced resistance just before the smart coil came out the tip of the px slim; therefore, it was removed.It was reported that the same issue occurred with another pc400; therefore, the px slim and pc400 were removed.The procedure was completed using a new px slim, other coils and four new pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report numbers: 3005168196-2018-01812, 3005168196-2018-01813.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coils 400 and a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance a smart coil through a px slim, the physician experienced resistance just before the smart coil came out the tip of the px slim; therefore, it was removed.It was reported that the same issue occurred with another pc400; therefore, the px slim and pc400 were removed.The procedure was completed using a non-penumbra microcatheter and four new pc400s.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: 7877649
• Report Number: 3005168196-2018-01811
• Device Sequence Number: 1986447
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 01/07/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F73601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005