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

Model Number	400SMTSFT0510
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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: 3005168196-2021-01171.3005168196-2021-01172.3005168196-2021-01173.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coil), a non-penumbra microcatheter, and a guidewire.During the procedure, a smart coil would not advance at all past its initial position within its introducer sheath.Therefore, the smart coil was removed.Subsequently, the same issue occurred with another smart coil.Therefore, the smart coil was also removed.It was reported that the introducer sheaths of the smart coils separated around the friction lock when force was used.Then, while attempting to advance the next smart coil, the physician experienced resistance.Therefore, the physician decided to re-sheath the smart coil.While re-sheathing the smart coil, resistance was encountered, and subsequently, the physician bent the pusher assembly of the smart coil.Therefore, the smart coil was removed.While attempting to advance another smart coil, it would not advance at all past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using nine smart coils, three non-penumbra coils, and 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 anterior cerebral artery (aca) using penumbra smart coils (smart coil), a non-penumbra microcatheter, and a guidewire.During the procedure, a smart coil would not advance at all past its initial position within its introducer sheath.Therefore, the smart coil was removed.Subsequently, the same issue occurred with another smart coil.Therefore, the smart coil was also removed.It was reported that the introducer sheaths of the smart coils separated around the friction lock when force was used.Then, while attempting to advance the next smart coil, the physician experienced resistance.Therefore, the physician decided to re-sheath the smart coil.While re-sheathing the smart coil, resistance was encountered, and subsequently, the pusher assembly of the smart coil became bent.Therefore, the smart coil was removed.The procedure was completed using nine smart coils, three 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 the penumbra clinical team on 01-july-2021: 1.Section b.Box 5.Describe event or problem.2.Section g.Box 3.Report source.It was previously understood that there were four smart coils that would not advance or resistance was experienced while re-sheathing.However, based on the additional information, there were only three smart coils that had this issue, not four.There was no allegation against a fourth smart coil.This report is associated with mfr report numbers: 1.3005168196-2021-01171; 2.3005168196-2021-01172; 3.3005168196-2021-01173.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: 11898380
• Report Number: 3005168196-2021-01174
• Device Sequence Number: 16490843
• Product Code: HCG
• UDI-Device Identifier: 00814548015101
• UDI-Public: 00814548015101
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2021
• 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: 06/09/2025
• Device Model Number: 400SMTSFT0510
• Device Catalogue Number: 400SMTSFT0510
• Device Lot Number: F98291
• 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: 05/10/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005