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

Catalog Number	400SMTSFT0715
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
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.This report is associated with mfr report number: 3005168196-2019-01470.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the smart coil "failed to deploy" after advancing through a non-penumbra microcatheter.Therefore, the smart coil was removed.The procedure was successfully completed using a new smart coil, the same handle, and the same microcatheter.There was no reported issue with the handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated approximately 1.0 cm on the proximal end of the pusher assembly.Bends and kinks were present throughout the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The pull wire was present within the pusher assembly ddt alignment feature.Offset coil winds were present throughout the embolization coil.Conclusions: evaluation of the returned smart coil revealed the pet lock was separated but not completely retracted on the proximal end of the pusher assembly.This likely allowed the embolization coil to remain intact with the pusher assembly ddt.During functional testing, a demonstration handle was used successfully to detach the embolization coil without an issue.The handle identified in the complaint was not returned for evaluation; therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed pusher assembly kinks and offset coil winds along the embolization coil.These damages 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: 3005168196-2019-01470.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8848642
• Report Number: 3005168196-2019-01469
• Device Sequence Number: 13960290
• Product Code: HCG
• UDI-Device Identifier: 00814548014722
• UDI-Public: 00814548014722
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 07/01/2019
• 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: 01/14/2024
• Device Catalogue Number: 400SMTSFT0715
• Device Lot Number: F87956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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