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

Model Number	400SMTSFT0515
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cerebral aneurysm using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, while the physician attempted to advance a smart coil in the aneurysm, the physician experienced resistance.Subsequently, only a partial of the smart coil was inserted into the aneurysm.It was then noticed that there was thrombus in the aneurysm that was not seen during the planning stages.Therefore, as the physician attempted to advance the smart coil more, it started to cause push back and prolapse the microcatheter instead of filling in around the thrombus.Therefore, the smart coil was removed.While the physician attempted to advance a new smart coil through the microcatheter, the physician experienced resistance.Subsequently, the smart coil would not advance through the distal end microcatheter after a few attempts were made.Therefore, the smart coil was removed and while attempting to re-sheath the smart coil, the hospital staff kinked the smart coil.The microcatheter was also removed to flush as it was clogged, and the physician then decided to continue the procedure using a new microcatheter.The procedure was completed using a new smart coil and a new microcatheter.There was no report of an adverse effect to the patient.
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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 510748-3200
• MDR Report Key: 12870935
• Report Number: 3005168196-2021-02683
• Device Sequence Number: 3547680
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021
• 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: 05/28/2023
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F83716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/31/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 21 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Date Report Sent to FDA: 01/01/2005