MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0830
Medical Device Problem Codes	Failure to Fold (1255); Structural Problem (2506); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed a pc400 coil into the aneurysm; however, the coil was not taking the intended 3d coiling pattern.Subsequently, the pc400 coil was removed from the patient.The physician then advanced the coil out into a bowl of saline and found that it came out straight and did not coil into a 3d pattern.Therefore, the procedure was completed using a new pc400 coil and another manufacturer's coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly; the embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device confirmed that the pc400 complex shape was present.The pc400 was deployed in a warm cup of water to simulate the body temperature and the intended shape was observed.Therefore, the pc400 was functional.The root cause of this complaint could not be determined.All penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5797012
• Report Number: 3005168196-2016-00986
• Device Sequence Number: 1241606
• Product Code: HCG
• UDI-Device Identifier: 00814548010939
• UDI-Public: 00814548010939
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

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: 11/30/2022
• Device Catalogue Number: 4004C0830
• Device Lot Number: F61560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2016
• Supplement Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR