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

Catalog Number	4002C0830
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2017
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: 3005168196-2017-01751.Hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hepatic artery using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance and was unable to advance a pc400 through the hub of a non-penumbra microcatheter; therefore, the pc400 was removed.The physician then successfully placed two non-penumbra coils using the microcatheter.The physician attempted to advance a new pc400, however again felt resistance and was unable to advance through the hub of the microcatheter.The physician therefore removed the pc400 and microcatheter, and flushed the microcatheter.The physician then reinserted the same microcatheter and re-attempted to advance the two pc400s, but was still unable to.The procedure was therefore completed using the same microcatheter, new pc400s, and additional coils.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: 6917894
• Report Number: 3005168196-2017-01752
• Device Sequence Number: 19197692
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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): 09/14/2017

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: 05/07/2024
• Device Catalogue Number: 4002C0830
• Device Lot Number: F69248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR