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

Catalog Number	400SMTXSFT0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Aneurysm rupture is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported ruptured aneurysm was an anticipated procedural complication.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2016-01519.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician initially placed a few smart coils into the aneurysm.While the physician was attempting to detach a new smart coil (lot #: unknown) in the aneurysm, the tip of the smart coil pusher assembly came out of the tip of the non-penumbra microcatheter.Subsequently, the aneurysm ruptured.The physician then readjusted the markers on the pusher assembly and microcatheter and successfully detached the smart coil.Next, a new smart coil was opened and placed in the aneurysm.The angiography revealed no further bleeding.The physician then attempted to place another smart coil (lot #: f68751) but encountered difficulty when the tip of the pusher assembly advanced approximately one centimeter from the tip of the microcatheter.Subsequently, the smart coil became entangled with the previously placed smart coil and unraveled.The pusher assembly then kinked.While the smart coil was being retracted, it unintentionally detached.The physician then advanced a non-penumbra guide wire through the catheter and subsequently, the detached coil inside the catheter came out.Therefore, the physician removed the microcatheter containing the detached coil from the patient's body.At the same time, the previously placed smart coil was inadvertently removed from the patient because it was entangled with the detached smart coil.The angiography then revealed that the aneurysm was bleeding again.The physician placed a non-penumbra balloon catheter to stop the bleeding and then completed the procedure using additional coils.Post-procedure, the patient is stable and recovering.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6441258
• Report Number: 3005168196-2017-00465
• Device Sequence Number: 302926
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 400SMTXSFT0202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening