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

Model Number	400SMTHXSFT0202
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-00297.
Event or Problem Description
The patient was undergoing a coil embolization procedure from the basilar artery to the superior cerebellar artery using penumbra smart coils (smart coils) and non-penumbra microcatheter.During the procedure, the physician implanted two smart coils and subsequently detached the third smart coil.On withdrawal, the pusher assembly of the smart coil was stuck in the hub of the microcatheter.The physician was able to remove the pusher assembly but was not able to insert the fourth smart coil into the microcatheter.The physician noted that there may have been some black particulate in the microcatheter.The microcatheter was removed, and the physician inserted a new microcatheter.When advancing the same smart coil in the microcatheter, the physician experienced resistance.Therefore, the smart coil was removed.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11341026
• Report Number: 3005168196-2021-00298
• Device Sequence Number: 4831286
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2021
• 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 Model Number: 400SMTHXSFT0202
• Device Catalogue Number: 400SMTHXSFT0202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/17/2021
• 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