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

Model Number	400SMTSFT0515
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 superior mesenteric artery (sma) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), non-penumbra coils, and a non-penumbra microcatheter.It should be noted that the patient's anatomy was mildly tortuous.During the procedure, the physician implanted six non-penumbra coils and three smart coils into the target vessel using the handle.After several attempts were made to implant the next smart coil using the handle, the coil would not detach.Therefore, the smart coil was removed.The procedure was completed using the same handle to detach another smart coil, four non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked in the multiple locations.The embolization coil was intact with its pusher assembly.The braided shaft was not exposed on the distal end of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed a kinked pusher assembly, broken pet lock, and the embolization coil intact with its pusher assembly.If the pusher assembly becomes kinked prior to an attempt to detach the coil, the kinks may pin the pull wire which may contribute resistance during retraction.Forceful retraction against resistance may result in the pull wire fracturing off the proximal end of the pusher assembly and prevent the embolization coil from detaching.The mildly tortuous patient¿s anatomy and the kinks in the pusher assembly may have contributed to resistance during use.During the functional test, the proximal end of the pusher assembly was fractured off by the penumbra investigator in order to gain access to the proximal end of the pull wire.The pull wire was retracted against resistance and fractured, and the embolization coil did not detach from its pusher assembly.Penumbra coils are visually inspected during in-process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 SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9825858
• Report Number: 3005168196-2020-00340
• Device Sequence Number: 1827960
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 06/17/2024
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F91078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/16/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005