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

Catalog Number	400SMTSTD0830
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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.This report is associated with mfr report number: 3005168196-2019-01014.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils) and a smart coil detachment handle (handle).During the procedure, the physician successfully placed a smart coil in the target location using a non-penumbra microcatheter and the handle.The physician then was unable to detach a second smart coil using neither the handle nor manual detachment.Therefore, the physician attempted to remove the smart coil; however, the smart coil detached while being retracted within the microcatheter.The physician then used a guidewire to place the detached smart coil in the target location.The procedure was then completed using a new microcatheter, a new coil, and two new smart coils.It was reported that a metal fragment from the pusher assembly of the second smart coil was found in the hub of the removed microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and pull tube was retracted into the hypotube on the proximal end of the pusher assembly.Bends and kinks were present throughout the pusher assembly.The pusher assembly was fractured approximately 6.5 cm from the proximal end and the distal detachment tip (ddt) was fractured on its distal end.Conclusions: evaluation of the returned smart coil revealed a separated pet lock.This type of damage typically occurs during an attempt to detach the embolization coil from its pusher assembly.Based on the return condition of the smart coil pusher assembly, non-penumbra microcatheter, and the handle not being returned for evaluation, functional testing could not be performed.Therefore, the root cause of the inability to detach the coil during the procedure could not be determined.Further evaluation revealed the ddt was fractured from the rest of the pusher assembly, a proximal fracture and pusher assembly kinks.If the device is forcefully retracted against resistance, damage such as a fractured ddt may occur.The proximal fracture and pusher assembly kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 8631746
• Report Number: 3005168196-2019-01013
• Device Sequence Number: 19246369
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019
• 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: 07/13/2022
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F78150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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