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

Catalog Number	4004C0715
Medical Device Problem Codes	Detachment Of Device Component (1104); Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).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.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400's (pc400's).During the procedure, the physician advanced a pc400 through the px slim delivery microcatheter (px slim) without experiencing any resistance but decided to retract the coil in order to reposition it.While retracting the pc400, the physician encountered slight resistance.Subsequently, the pc400 became stretched and unintentionally detached within the px slim.Therefore, the physician pushed the pc400 into the target vessel using the pusher assembly and then completed the procedure using new penumbra smart coils, pod coils and the same px slim.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained a continuous flush during the procedure.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6297650
• Report Number: 3005168196-2017-00142
• Device Sequence Number: 13766022
• Product Code: HCG
• UDI-Device Identifier: 00814548010908
• UDI-Public: 00814548010908
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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: 05/31/2023
• Device Catalogue Number: 4004C0715
• Device Lot Number: F64134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1