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

Model Number	400SMTHXSFT1H01
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
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 middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance at all 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 broken on the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The pusher assembly was kinked approximately 138.0 cm from the proximal end.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock and the pusher assembly was kinked.If this occurs, resistance may be experienced during advancement of the smart coil through its introducer sheath.Forceful advancement against resistance may result in the pusher assembly kink.During functional testing, resistance was experienced while attempting to advance the pusher assembly mid-joint through the introducer sheath friction lock; therefore, the introducer sheath was removed distally.The introducer sheath could not be advanced over the kink in the pusher assembly, and therefore, the smart coil could not be functionally tested.Further evaluation of the returned smart coil revealed that the pet lock was broken on the proximal end of the pusher assembly.This damage was likely incidental to the reported complaint.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.H3 other text: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10072208
• Report Number: 3005168196-2020-00662
• Device Sequence Number: 19771375
• Product Code: HCG
• UDI-Device Identifier: 00814548015637
• UDI-Public: 00814548015637
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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): 05/01/2020
• 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: 05/22/2024
• Device Model Number: 400SMTHXSFT1H01
• Device Catalogue Number: 400SMTHXSFT1H01
• Device Lot Number: F90540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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