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

Catalog Number	400SMTXSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.Bends were present throughout the length of the pusher assembly.The pusher assembly was kinked approximately 136.5 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the first returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, resistance was experienced while attempting to advance the smart coil within its introducer sheath; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed properly.Subsequently, the smart coil was advanced through its introducer sheath and a demonstration microcatheter without an issue.Further evaluation revealed a kink near the pusher assembly mid-joint and bends along the pusher assembly.The kink was likely a result of mishandling during advancement against resistance.The bends were likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, resistance was experienced while attempting to advance the smart coil within its introducer sheath; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed properly.Subsequently, the smart coil was advanced through its introducer sheath and a demonstration microcatheter without an issue.Further evaluation revealed bends along the pusher assembly.These bends were likely incidental to the reported complaint.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.This report is associated with mfr report number: 3005168196-2019-02338.
Event or Problem Description
The patient was undergoing a coil embolization procedure using in the middle cerebral artery (mca) using penumbra smart coils (smart coils) and non-penumbra microcatheter.During the procedure, the physician inserted a smart coils into the hub of the microcatheter; however, the smart coil would not advance at all within its introducer sheath; therefore, it was removed.The physician then inserted a new smart coil into the hub of the microcatheter; however, the smart coil would not advance at all within its introducer sheath and, therefore, it was removed.The procedure was completed using new smart coils and the same microcatheter.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: 9475125
• Report Number: 3005168196-2019-02337
• Device Sequence Number: 14141020
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 11/20/2019
• 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: 02/14/2024
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F88575
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/16/2019
• 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