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

Catalog Number 400SMTHXSFT0202

Device Problems Detachment Of Device Component (1104); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pusher assembly was severely damaged.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was severely damaged.This damage likely occurred during packaging of the device for return to penumbra.Based on the returned condition of the device, the root cause of the reported kick back during detachment could not be determined.Evaluation of the returned handle revealed that the device was functional.The handle was functionally tested on the handle fixture for pull force and throw distance and passed for both within specification.The non-penumbra microcatheter and the smart coil embolization coil identified in the complaint were not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a smart coil detachment handle (handle).During the procedure, the physician successfully placed multiple coils and a smart coil using a non-penumbra microcatheter.The physician then advanced another smart coil into the target location, however, while attempting to detach the smart coil using the handle, the smart coil kicked back into the microcatheter.The smart coil unintentionally detached, and the physician then used the pusher assembly to push the smart coil into the target location.The physician then felt resistance and was unable to advance a guidewire past the last 1-2 cm from the tip of the microcatheter.The physician retracted the microcatheter out of the aneurysm, and then removed all of the devices.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7545253
• MDR Text Key: 109300550
• Report Number: 3005168196-2018-01048
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F75051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1