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

Catalog Number	400SMTSFT4H10
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was implanted in the patient and is no longer available for return.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: 3005168196-2017-01869, 3005168196-2017-01870, 3005168196-2017-01871, 3005168196-2017-01872.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cerebral aneurysm (ba-top) using penumbra smart coils (smart coils) and penumbra smart coil detachment handles (handles).During the procedure, the physician deployed two smart coils into the target vessel but was unable to detach the coils using the handle.After a couple of attempts using the same handle, both coils finally detached successfully.The physician then deployed a new smart coil in the target and attempted to detach it using a new handle.After the first attempt, it was confirmed that the black alignment zone (pet lock) on the coil pusher assembly became separated about three millimeters.After making additional attempts, the black alignment zone peeled off and pulled into the handle.It was fluoroscopically observed that the smart coil was detached successfully.The procedure was completed using non-penumbra 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: 6967020
• Report Number: 3005168196-2017-01873
• Device Sequence Number: 1221909
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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: 10/09/2021
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F71989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR