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

Catalog Number	400SMTXSFT011H
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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 right middle cerebral artery (rmca) using penumbra smart coils (smart coil).During the procedure, the physician experienced resistance after advancing a smart coil through the rotating hemostasis valve (rhv) and past the hub of the non-penumbra microcatheter; therefore, the smart coil was removed.The procedure was completed using new smart coils with the same rhv and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was present on the proximal end of the penumbra smart coils (smart coil) pusher assembly.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).The introducer sheath had a slight ovalization approximately 6.0 cm from the distal end.Conclusions: evaluation of the returned smart coil revealed the introducer sheath was slightly ovalized on its distal end.If an rotating hemostasis valve (rhv) is over-tightened on the introducer sheath, damage such as this may occur, and resistance may be experienced during advancement of the smart coil through its introducer sheath.During functional testing, the smart coil was advanced through a demonstration rhv and microcatheter without issue.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.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: 8699661
• Report Number: 3005168196-2019-01151
• Device Sequence Number: 16555109
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 05/15/2019
• 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: 03/18/2023
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F82420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 72
• Date Report Sent to FDA: 01/01/2005