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

Model Number	400SMTSFT0308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal thoracic artery using penumbra smart coils (smart coils), a non-penumbra microcatheter, and a diagnostic catheter.During the procedure, the physician implanted thirty-two smart coils and eight non-penumbra coils into the target location.While attempting to advance the next smart coil, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using another smart coil with the same microcatheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal thoracic artery using penumbra smart coils (smart coils), a non-penumbra microcatheter, and a diagnostic catheter.During the procedure, the physician implanted thirty-two smart coils and eight non-penumbra coils into the target location.While attempting to advance the next smart coil, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using another smart coil and sixty-three other coils with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on (b)(6) 2021: 1.Section b.Describe event or problem 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: 12109037
• Report Number: 3005168196-2021-01463
• Device Sequence Number: 17070019
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• 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,Followup
• Report Date (Section B): 08/09/2021
• 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: 01/07/2023
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F81326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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