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

Catalog Number	400SMTSFT0203
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
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.3005168196-2016-01819.The device is implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating an arteriovenous fistula using penumbra smart coils (smart coil) and penumbra smart coil detachment handles (handle).During the procedure, the physician successfully deployed and detached the initial smart coils using the handle.While attempting to detach a new smart coil using the same handle, the smart coil failed to detach on the first attempt; however, the smart coil then successfully detached on the second attempt.It was noted that after detaching the smart coil, it was difficult to remove the smart coil pusher assembly from the handle.The procedure was then completed using additional smart coils and a new handle.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: 6171358
• Report Number: 3005168196-2016-01820
• Device Sequence Number: 976554
• Product Code: HCG
• UDI-Device Identifier: 00814548015118
• UDI-Public: 00814548015118
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2016

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: 08/12/2020
• Device Catalogue Number: 400SMTSFT0203
• Device Lot Number: F65282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63