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

Catalog Number	400SMTXSFT0408
Medical Device Problem Codes	Detachment Of Device Component (1104); Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and the distal detachment tip (ddt) was separated from pusher assembly.Conclusions: evaluation of the returned smart coil revealed the embolization coil was detached, the ddt was separated from the pusher assembly, and the non-penumbra microcatheter was kinked and fractured near its hub.If the smart coil is forcefully advanced through a damaged microcatheter, the ddt may separate from the pusher assembly.Separation of the ddt from the pusher assembly will cause the embolization coil to detach from the pusher assembly.Since the ddt was separated and the embolization coil was detached, the root cause of the inability to advance the smart coil could not be determined.Penumbra coils and catheters 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.
Event or Problem Description
The patient was undergoing a coil and pipeline embolization procedure in the posterior cerebral artery (pca) using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil more than slightly into the hub of a non-penumbra microcatheter.The physician attempted to manipulate the smart coil to advance; consequently, the smart coil unintentionally detached while partially advanced into the microcatheter.The physician was unable to advance any other coils through the microcatheter because the smart coil was stuck within the microcatheter; therefore the microcatheter was removed.The procedure was continued using additional pipeline devices.It was noted that the physician will further evaluate at a follow up angiogram.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Report source.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6824643
• Report Number: 3005168196-2017-01436
• Device Sequence Number: 11093864
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017
• 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: Physician
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F74143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005