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

Catalog Number 400SMTHXSFT1H03

Device Problems Bent (1059); Detachment Of Device Component (1104); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the smart coil pusher assembly was kinked approximately 11.0, 12.0, 28.0, and 65.0 cm from the proximal end.The smart coil was fractured approximately 66.0 cm from the proximal end.Conclusions: evaluation of the device revealed a fractured pusher assembly.This damage was likely a result of forceful handling during use.If the pusher assembly is forcefully manipulating at extreme angles it may become kinked.Further forceful manipulation of the pusher assembly may cause it to become fractured.Further evaluation revealed multiple kinks along the pusher assembly¿s length.This damage was likely incidental and reportedly occurred during packaging for return to penumbra facilities.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.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, after successfully deploying and detaching multiple smart coils in the target vessel using a non-penumbra microcatheter, the physician accidentally kinked a smart coil pusher assembly while attempting to advance it into the microcatheter.Therefore, the smart coil was removed and while unintentionally detached as the technician was winding the it outside the patient.The procedure was then completed using the same non-penumbra microcatheter and additional smart coils.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: 6457476
• MDR Text Key: 71687631
• Report Number: 3005168196-2017-00538
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 00814548015668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/15/2020
• Device Catalogue Number: 400SMTHXSFT1H03
• Device Lot Number: F66522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2015
• 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
• Patient Age: 73 YR