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

Catalog Number	400SMTXSFT0406
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
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.This report is associated with mfr report numbers: 3005168196-2019-00753, 3005168196-2019-00754.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a smart coil detachment handle (handle).During the procedure, the physician attempted to place a smart coil in the target location; however, the physician was unable to detach the smart coil using the handle, despite attempting three times.Therefore, the smart coil was removed and a new smart coil was successfully placed.The physician then attempted to place another smart coil in the target location; however, the smart coil did not take its intended shape.The physician attempted to reposition the smart coil; however, the coil would not form correctly.Therefore, the smart coil was removed and the procedure was completed using a new smart coil, the same microcatheter, and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated approximately 1.5 cm on the proximal end of the pusher assembly.The pusher assembly braided shaft was exposed.The pusher assembly was kinked approximately 173.5 cm from the proximal end.The embolization coil was intact with the distal detachment tip (ddt).The pull wire was within the alignment feature of the ddt.Offset coil winds were present along the embolization coil.The total length of the pusher assembly was approximately 183.5 cm.Conclusions: evaluation of the first returned smart coil revealed the braided shaft was exposed.If the braided shaft is exposed and an attempt is made to detach the coil, the pusher assembly may shorten, and the pull wire will not retract out of the ddt.If this occurs, the embolization coil will likely not detach.During functional testing, the smart coil was attempted to be detached using a demonstration handle, but embolization coil would not detach.The root cause of the damage to the braided shaft could not be determined.Evaluation of the second returned smart coil was unable to confirm the reported inability to take shape.During functional testing, the smart coil took its intended shape.The root cause of the complaint could not be determined.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.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of damage to the braided shaft.This report is associated with mfr report numbers: 3005168196-2019-00753 and 3005168196-2019-00754.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8531638
• Report Number: 3005168196-2019-00752
• Device Sequence Number: 16624318
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• Combination Product (Y/N): Y
• Initial Reporter Country: GT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019
• 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: 05/10/2022
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F79960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Date Report Sent to FDA: 01/01/2005