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

Catalog Number	400SMTXSFT1H04
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
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 in the anterior communicating artery (acom) 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 another smart coil and 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 its pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned smart coil confirmed that the device could not be advanced within its introducer sheath.During the functional test, resistance was encountered while attempting to advance the smart coil¿s pusher assembly within its introducer sheath, and the friction lock on the proximal end of its introducer sheath fractured off.The smart coil could not be advanced any further.The root cause of the smart coil not advancing within its introducer sheath could not be determined.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: 9214136
• Report Number: 3005168196-2019-01959
• Device Sequence Number: 11410188
• Product Code: HCG
• UDI-Device Identifier: 00814548015248
• UDI-Public: 00814548015248
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2019
• 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: 10/08/2022
• Device Catalogue Number: 400SMTXSFT1H04
• Device Lot Number: F79869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/22/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005