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

Catalog Number	400SMTSFT1030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Dried blood was found within the introducer sheath.Conclusions: evaluation of the returned smart coil revealed an undamaged, functional device with dried blood within the introducer sheath.If the introducer sheath is occluded, resistance may be experienced while advancing the smart coil within the introducer sheath.During functional testing, the dried blood was cleared, and the introducer sheath was re-seated onto the pusher assembly mid-joint.The smart coil was then advanced out of the introducer sheath and through a demonstration microcatheter without an issue.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a penumbra smart coils (smart coil).During the procedure, after advancing a smart coil approximately 10 centimeters within the introducer sheath, the smart coil became stuck and would not advance any further; therefore, it was removed.The procedure was completed using a new smart coil.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: 9088477
• Report Number: 3005168196-2019-01789
• Device Sequence Number: 2425273
• Product Code: HCG
• UDI-Device Identifier: 00814548014791
• UDI-Public: 00814548014791
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019
• 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: 03/15/2022
• Device Catalogue Number: 400SMTSFT1030
• Device Lot Number: F75045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• 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: 08/22/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 62
• Date Report Sent to FDA: 01/01/2005