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

Model Number	400SMTHXSFT0206
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
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 internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance from the starting position within the introducer sheath.Therefore, the smart coil was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the smart coil pusher assembly had bends had kinks throughout its length.The pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted.The embolization coil was detached from the pusher assembly and was not returned for evaluation.Conclusions: evaluation of the first returned smart coil could not confirm the reported complaint as the device was returned without its introducer sheath.Further evaluation revealed that the pet lock was separated and the pull wire was retracted on the proximal end of the pusher assembly, the pusher assembly had bends and kinks throughout its length and the embolization coil was detached and not returned for evaluation.The observed damages were not mentioned in the reported complaint and are likely incidental.Evaluation of the second returned smart coil revealed that the pet lock was separated on the proximal end of the pusher assembly, the pusher assembly had kinks along its length, and the embolization coil was intact with its pusher assembly and was partially advanced out of the introducer sheath.This device was not mentioned in the reported complaint; therefore, the observed damages may be incidental to the 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.Section h.Box 6.Conclusions code 1: 4316 the investigation findings do not lead to a clear conclusion about the root cause of smart coil advancement issue.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10853300
• Report Number: 3005168196-2020-02017
• Device Sequence Number: 14058261
• Product Code: HCG
• UDI-Device Identifier: 00814548015972
• UDI-Public: 00814548015972
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 10/23/2020
• 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: 03/19/2024
• Device Model Number: 400SMTHXSFT0206
• Device Catalogue Number: 400SMTHXSFT0206
• Device Lot Number: F89172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005