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

Model Number	400SMTSTD1460
Medical Device Problem Code	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	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid communicating segment using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, the physician experienced resistance and was only able to advance the smart coil partially within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using a new smart coil and other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured approximately 51.0 cm from the distal detachment tip (ddt).The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was detached from its pusher assembly inside the introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and the pusher assembly was fractured.If the pusher assembly mid-joint is retracted proximal to the introducer sheath friction lock, resistance may be experienced during advancement.Forceful advancement against this resistance may have contributed to a kink in the pusher assembly.Further manipulation of a kinked device may result in a fracture.The proximal fractured segment of the pusher assembly was not returned for evaluation.Further evaluation of the returned smart coil revealed that the embolization coil was detached inside its introducer sheath.This was likely incidental to the reported complaint and may have occurred due to the pull wire being retracted out of the ddt after the pusher assembly was fractured.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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
• MDR Report Key: 10804585
• Report Number: 3005168196-2020-01920
• Device Sequence Number: 3799802
• Product Code: HCG
• UDI-Device Identifier: 00814548014289
• UDI-Public: 00814548014289
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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): 10/13/2020
• 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: 05/31/2025
• Device Model Number: 400SMTSTD1460
• Device Catalogue Number: 400SMTSTD1460
• Device Lot Number: F98104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005