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

Catalog Number	4002C0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2017
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 numbers: 3005168196-2017-01817, 3005168196-2017-01819.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization in the right subclavian artery using penumbra coils 400 (pc400s).During the procedure, the physician advanced a non-penumbra catheter and microcatheter in the target vessel then placed a non-penumbra coil in the aneurysm.While attempting to place a pc400 in the target vessel, the physician noticed that the coil was not taking its intended shape.The physician then experienced resistance while attempting to advance and retract the pc400 and subsequently, the pc400 became unraveled.Therefore, the physician attached a syringe to the back of the microcatheter and pulled negative pressure back.The microcatheter containing the pc400 was then removed and the coil was flushed out.After that, the microcatheter was reinserted into the patient and the physician advanced a new pc400 into the aneurysm.The physician then attempted to detach the pc400 using a penumbra coil 400 detachment handle (handle).Without realizing that the pc400 failed to detach, the physician attempted to retract the pc400 pusher assembly; however, it was noticed under fluoroscopy that the pc400 was still attached to its pusher assembly.Therefore, the physician decided to re-advance the pc400 into the aneurysm; however, the pc400 unintentionally detached approximately five centimeters from the tip of the microcatheter.Therefore, the physician used a syringe to flush the detached coil in the aneurysm.The procedure was ended at this point.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: 6962230
• Report Number: 3005168196-2017-01818
• Device Sequence Number: 11068070
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 12/01/2023
• Device Catalogue Number: 4002C0830
• Device Lot Number: F66783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR