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

Catalog Number	400SMTSFT0410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
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 internal iliac artery (iia) using penumbra smart coils (smart coils).During the procedure, the physician placed five smart coils and nine non-penumbra coils in the target vessel using a non-penumbra microcatheter.While attempting to insert a new smart coil into the microcatheter, the physician experienced resistance and the smart coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using three additional smart coils and three other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher had bends and kinks approximately 15.0 cm, 31.0 cm, 31.5 cm, 33.0 cm, 71.0 cm, 132.5 cm and 136.0 cm from the proximal end.The smart coil assembly was intact.The proximal end of the embolization coil was stretched.The embolization coil had offset coil winds throughout the coil.Conclusion: evaluation of the returned smart coil revealed a device with offset coil winds and pusher assembly kinks.The introducer sheath was not returned with the subject smart coil.During functional testing, the smart coil was able to be re-sheathed within a demonstration introducer sheath.The coil was able to be advanced out of its sheath with strong resistance due to the coil damage and pusher assembly kinks but was unable to advance into a demonstration microcatheter.If the smart coil is forcefully advanced against resistance, damage such as pusher assembly kinks may occur.Based on the reported complaint and returned condition, the offset coil winds were likely incidental to the complaint and may have occurred during packaging for return to penumbra.The root cause of the initial resistance was unable to be determined.Penumbra coils are 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: 8099866
• Report Number: 3005168196-2018-02303
• Device Sequence Number: 13934048
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 00814548015095
• 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): 10/24/2018
• 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 Catalogue Number: 400SMTSFT0410
• Device Lot Number: F81325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005