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

Catalog Number	4002C0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
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: 3005168196-2017-02055.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a thoracic artery aneurysm using a penumbra coil 400 detachment handles (handles) and penumbra coil 400s (pc400s).During the procedure, the physician placed a non-penumbra stent graft toward the treatment site, then advanced a non-penumbra support microcatheter into the left subclavian artery.After that, the physician placed three non-penumbra coils and five pc400s in the target vessel.Thereafter, the physician advanced a new pc400 in the target vessel and attempted to detach it using the handle; however, the pc400 failed to detach.Therefore, the physician tried to adjust the position of the pc400 by using the push and pull technique.While attempting to push and retract the pc400, the physician did not mention resistance; however, the pc400 unintentionally detached in the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil from the patient¿s body and flushed to coil out.The physician then reinserted the same microcatheter in target vessel and the procedure was completed using three other pc400s and a new handle.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: 7030939
• Report Number: 3005168196-2017-02054
• Device Sequence Number: 16397387
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 04/19/2025
• Device Catalogue Number: 4002C0830
• Device Lot Number: F75804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR