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

Catalog Number	400SMTXSFT0406
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly of the penumbra smart coil (smart coil) evaluated was kinked in multiple locations throughout its length.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusion: the smart coils were returned entangled with each other and bent in multiple locations, all within one specimen bag.These return packaging conditions likely contributed to the damage observed on the smart coil pusher assemblies and were incidental to the reported complaint.The first and second smart coils had their embolization coils detached.Since the smart coils were reported as successfully removed from the procedure and there was no report of detachment, these detachments were also likely incidental, and were likely caused by the return packaging conditions.The smart coils could not be functionally tested for advancement into a demonstration microcatheter due to the observed incidental damage and, therefore, the root cause of the reported 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.This report is associated with mfr report numbers: 3005168196-2017-01569, 3005168196-2017-01570.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils.During the procedure, the physician successfully deployed and detached multiple smart coils using a non-penumbra microcatheter.The physician was then unable to advance three smart coils out of their introducer sheaths and into the hub of the microcatheter; therefore, the smart coils were removed.The procedure was completed using additional smart coils and the same microcatheter.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.This report is associated with mfr report numbers: 3005168196-2017-01569.3005168196-2017-01570.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6856316
• Report Number: 3005168196-2017-01571
• Device Sequence Number: 16258566
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017
• 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: 02/02/2022
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F74198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005