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

Catalog Number	400SMTSFT0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
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, after inserting a smart coil into the rotating hemostasis valve (rhv) of a non-penumbra microcatheter, the smart coil would not advance from its starting position; therefore, it was removed.The procedure was completed using another smart coil and the same microcatheter.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 pusher assembly.The pusher assembly was kinked approximately 9.0 and 137.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The inner diameter (id) of the introducer sheath and the outer diameter of the pusher assembly mid-joint were measured within specification.Resistance was encountered as the pusher assembly was advanced from its starting position and as the kinks in the pusher assembly were advanced through the introducer sheath; however, the smart coil was able to advance through a demonstration microcatheter and out of the distal tip.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kinked pusher assembly may occur.The root cause of resistance could not be determined.The id of the introducer sheath and the od of the pusher assembly mid-joint was measured within specification.During the functional test, resistance while advancing the smart coil from its starting position and as the kinks in the pusher assembly were being advanced through the introducer sheath.However, the smart coil was able to advance completely through the demonstration microcatheter and out of the distal tip.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: 7555557
• Report Number: 3005168196-2018-01080
• Device Sequence Number: 2029622
• Product Code: HCG
• UDI-Device Identifier: 00814548015033
• UDI-Public: 00814548015033
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 05/04/2018
• 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: Physician
• Device Expiration Date: 10/24/2022
• Device Catalogue Number: 400SMTSFT0304
• Device Lot Number: F80180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005