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

Model Number	400SMTSFT0308
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
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.This report is associated with mfr report numbers: 3005168196-2021-01950 3005168196-2021-01952, 3005168196-2021-01953, 3005168196-2021-01954.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician successfully placed three smart coils in the target location using the microcatheter.While advancing the next smart coil approximately a few centimeters into the microcatheter, the physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was removed.Next, while advancing another smart coil approximately a few centimeters into the microcatheter, the same issue occurred.The physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was also removed.Afterwards, the next three smart coils advanced slightly past their initial positions within their respective introducer sheaths before becoming stuck within their respective introducer sheaths.Therefore, the three smart coils were removed.The procedure was completed using a new smart coil, five non-penumbra 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 is being updated based on additional information provided by a (b)(4) distributor on 09/13/2021: this report is associated with mfr report numbers: 1.3005168196-2021-01950, 2.3005168196-2021-01952, 3.3005168196-2021-01953, 4.3005168196-2021-01954, and 5.3005168196-2021-02230.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician successfully placed three smart coils in the target location using the microcatheter.While advancing the next smart coil approximately a few centimeters into the microcatheter, the physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was removed.Next, while advancing another smart coil approximately a few centimeters into the microcatheter, the same issue occurred.The physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was also removed.Afterwards, the next three smart coils advanced slightly past their initial positions within their respective introducer sheaths before becoming stuck within their respective introducer sheaths.Therefore, the three smart coils were removed.It was also reported that the physician attempted to advance another smart coil to the target location; however, the physician was unable to advance the smart coil to the target location.Therefore, the smart coil was removed.The procedure was completed using a new smart coil, five non-penumbra coils and the same microcatheter.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: 12419032
• Report Number: 3005168196-2021-01951
• Device Sequence Number: 11641660
• 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): 10/13/2021
• 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: 06/09/2025
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F98287
• 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: 08/12/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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