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

Model Number	400SMTHXSFT0308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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 number: 3005168196-2021-02009.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician placed some smart coils into the target location using the microcatheter.Afterwards, two smart coils would not advance at all from their initial position within their respective introducer sheaths.Therefore, the two smart coils were removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil confirmed the reported complaint that the coil could not be advanced from its initial position.Evaluation revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This is likely the probable cause of the reported complaint as resistance will likely be encountered if this occurs.Forceful advancement against this resistance likely contributed to the pusher assembly kinks observed near the mid-joint.During functional testing, the smart coil was only able to advance from its returned position within the introducer sheath slightly before additional resistance caused by the pusher assembly kink was encountered, and the coil could not advance any further.Evaluation of the second returned smart coil confirmed the reported complaint that the coil could not be advanced from its initial position.Evaluation revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This is likely the probable cause of the reported complaint as resistance will likely be encountered if this occurs.Forceful advancement against this resistance likely contributed to the pusher assembly kinks and fracture observed near the mid-joint.Further evaluation revealed the embolization coil was detached from the pusher assembly.This damage is incidental to the complaint and was likely a result of the pusher assembly fracture.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.The following results code also applies: 114 this report is associated with mfr report number: 3005168196-2021-02009.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: 12457572
• Report Number: 3005168196-2021-02010
• Device Sequence Number: 16455175
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 00814548015798
• 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): 09/10/2021
• 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: 11/16/2025
• Device Model Number: 400SMTHXSFT0308
• Device Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F102081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/11/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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