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

Catalog Number	400SMTSFT0615
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance within its introducer sheath; 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 was kinked approximately 68.0, 122.0, 136.5, and 138.0 cm from the proximal end.The pusher assembly was fractured approximately 137.5 cm from its proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and friction lock was compressed.The pull wire was retracted out of the distal fractured segment of the pusher assembly and the embolization coil was detached from its pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted beyond the introducer sheath friction lock, and the pusher assembly was kinked and fractured.If the pusher assembly mid-joint is retracted beyond the introducer sheath friction lock, resistance may be encountered during advancement and damage such as a kink may occur.Further manipulation of a kinked pusher assembly may result in a fracture.Further evaluation of the returned smart coil revealed that the pull wire was completely retracted out of the distal fracture segment of the pusher assembly and the embolization coil was detached from its pusher assembly.This damage was likely incidental to the reported complaint and was likely a result of the pusher assembly becoming fractured.The embolization coil was not returned for evaluation.Penumbra coil 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: 9076263
• Report Number: 3005168196-2019-01753
• Device Sequence Number: 19458755
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• 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): 08/18/2019
• 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: 02/26/2024
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F88709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/18/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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