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

Catalog Number	400SMTSTD0510
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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 renal artery using penumbra smart coils (smart coils), ruby coils, and a non-penumbra microcatheter.During the procedure, the physician successfully advanced ruby coils through the microcatheter and implanted them into the target vessel.The physician then decided to use a 5mm x 10cm smart coil with the same microcatheter.It was reported that the 5mm x 10cm smart coil was advanced into the microcatheter several times but was unable to advance out.Subsequently, the 5mm x 10cm smart coil became bent in the microcatheter.Therefore, the 5mm x 10cm smart coil was removed.The procedure was completed using another 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 pusher assembly.Kinks were present along the length of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was kinked, and the embolization coil had offset winds.Based on the complaint, the smart coil was advanced through a non-penumbra microcatheter which has a larger inner diameter than smart coils are intended to be delivered through.The larger inner diameter of the non-penumbra microcatheter would allow the smart coil to begin to prolapse and coil upon itself, thus causing resistance.Forcefully advancing the device against the resistance may result in the pusher assembly becoming kinked and offset coil winds on the embolization coil.Further investigation revealed additional pusher assembly kinks.These kinks were likely incidental and could have occurred during packaging for return to penumbra.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: 9370503
• Report Number: 3005168196-2019-02203
• Device Sequence Number: 16700370
• Product Code: HCG
• UDI-Device Identifier: 00814548014630
• UDI-Public: 00814548014630
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019
• 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: 02/03/2021
• Device Catalogue Number: 400SMTSTD0510
• Device Lot Number: F67728
• 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: 10/30/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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