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

Catalog Number	400SMTXSFT1H03
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
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.This report is associated with mfr report numbers: 3005168196-2018-02504; 3005168196-2018-02505.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician was unable to detach two smart coils using the handle.The procedure was completed using other smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and retracted at the proximal end of the pusher assembly.Multiple bends and kinks were present along the length of the pusher assembly.The embolization coil had offset coil winds and was detached from the pusher assembly ddt.Conclusions: evaluation of the first returned smart coil revealed a separated pet lock and a detached embolization coil.The proximal pet lock being separated indicates a pull force was applied to the proximal end typically in an attempt to detach the coil.If the pet lock is separated and retracted, the embolization coil will become detached.The root cause of the failure to detach during the procedure could not be determined.Further evaluation revealed pusher assembly kinks and embolization coil damage.These damages were likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed a detached embolization coil stuck within the returned non-penumbra microcatheter with an unknown substance.This substance may have contributed to the difficulty using the device.The pet lock was intact.If the handle is not properly seated on the proximal end of the coil, the pet lock may not become separated and the coil will not detach.Further evaluation revealed multiple bends and kinks on the device.These damages were likely incidental to the reported complaint.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.This report is associated with mfr report numbers: 3005168196-2018-02504 and 3005168196-2018-02505.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8191508
• Report Number: 3005168196-2018-02503
• Device Sequence Number: 11423253
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• 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): 11/26/2018
• 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: 12/01/2021
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F80096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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