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

Catalog Number	400SMTSFT0715
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
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: 3005168196-2018-00067, 3005168196-2018-00068, 3005168196-2018-00069, 3005168196-2018-00070, 3005168196-2018-00071.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils.During the procedure, two smart coils (f77124, c03494) were advanced and implanted using a non-penumbra microcatheter, and after being detached, the proximal ends of the coils migrated out of the aneurysm, so the smart coils were only partially within the aneurysm.Next, two other smart coils (f78441, f78758) felt gritty and were not able to be advanced into the microcatheter, and therefore the smart coils were removed.The physician then was unable to advance a smart coil (f74006) out of its introducer sheath, and therefore the smart coil was not used in the procedure.The physician was able to advance a sixth smart coil (f74006) through the rhv, but was unable to advance it into the hub of the microcatheter, and therefore the smart coil was removed.Next, the physician was unable to advance the seventh smart coil (f73219) out of its introducer sheath and into the microcatheter, and therefore the smart coil was removed.The procedure was then completed using additional smart coils.The physician also deployed two stents into the left and right posterior cerebral artery (pca) to protect the neck of the basilar artery as well as to pin down the protruding tips of the first two smart coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7171928
• Report Number: 3005168196-2018-00066
• Device Sequence Number: 10943532
• Product Code: HCG
• UDI-Device Identifier: 00814548014722
• UDI-Public: 00814548014722
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/15/2022
• Device Catalogue Number: 400SMTSFT0715
• Device Lot Number: F77124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/08/2018
• 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: Required Intervention
• Patient Age: 78