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

Catalog Number	400SMTSFT0610
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
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 to treat a basilar tip aneurysm using penumbra smart coils.During the procedure, a smart coil would not advance at all within its introducer sheath, despite multiple attempts; therefore, it was removed.The procedure was completed using a new smart coil.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was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The inner diameter (id) of the friction lock is smaller than the rest of the introducer sheath which allows it to seat properly on the pusher assembly mid-joint.If the pusher assembly mid-joint is retracted proximal to the introducer sheath friction lock during use, resistance may be experienced while advancing.During functional testing, the introducer sheath was removed distally, and the smart coil was re-sheathed.The smart coil was then advanced out of its introducer sheath and through a demonstration microcatheter without an issue.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: 8459469
• Report Number: 3005168196-2019-00559
• Device Sequence Number: 2746394
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019
• 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: 08/14/2023
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F85232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005