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

Catalog Number	400SMTHXSFT0510
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2018
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 posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a smart coil in the target vessel using a px slim delivery microcatheter (px slim).The physician then attempted to advance a new smart coil, however, the smart coil became stuck within the microcatheter.Therefore, it was removed.The procedure was completed using six additional smart coils and the same microcatheter.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had multiple bends and kinks along the length of the device.The pull wire pet bump was distal to the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly.The embolization coil had offset coil winds throughout the length of the coil.Conclusions: evaluation of the returned smart coil revealed a detached embolization coil that had offset coil winds.The device was returned detached and damaged; any damage that may have been present during the procedure is undiscernible from the damage caused by packing up the device and being returned.The cause of the reported complaint was unable to be determined.The reported complaint mentioned resistance was present when the device became stuck within the microcatheter.If the device is forcefully advanced against resistance, damage such as offset coil winds or the distal pet bump coming out of the pusher assembly distal detachment tip (ddt) may occur.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 SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8028960
• Report Number: 3005168196-2018-02153
• Device Sequence Number: 1664072
• Product Code: HCG
• UDI-Device Identifier: 00814548015859
• UDI-Public: 00814548015859
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018
• 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: 01/01/2023
• Device Catalogue Number: 400SMTHXSFT0510
• Device Lot Number: F81246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005