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

Catalog Number	400SMTXSFT0205
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2016
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: 3005168196-2016-00451, 3005168196-2016-00452, 3005168196-2016-00453.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery using penumbra smart coils (smart coils).During the procedure, the physician successfully implanted three smart coils into the patient.The physician then inserted a fourth smart coil into the patient; however, the coil was not implanted and was removed because the microcatheter kicked out of the aneurysm.The procedure was completed at this point.During a routine follow up visit, the angiography revealed that at least two of the three implanted smart coils were herniating out of the aneurysm neck and into the parent vessel.The physician did not perform any intervention because the patient was already on an anticoagulant regimen of aspirin and eliquis.The patient was stable and asymptomatic.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: 5556218
• Report Number: 3005168196-2016-00454
• Device Sequence Number: 16230623
• Product Code: HCG
• UDI-Device Identifier: 00814548015293
• UDI-Public: 00814548015293
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2016

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: 11/04/2020
• Device Catalogue Number: 400SMTXSFT0205
• Device Lot Number: F66369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2016
• Initial Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1