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

Model Number 400SMTSFT0515

Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

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 Description

The patient was undergoing a coil embolization procedure to treat a arteriovenous fistula (davf) using penumbra smart coils (smart coils), non-penumbra coils, a non-penumbra microcatheter, a non-penumbra catheter, and a non-penumbra guide catheter.During the procedure, the physician implanted nine non-penumbra coils.Subsequently, a smart coil would not advance beyond its initial position within its introducer sheath.The physician continued attempting to advance the smart coil; however, the pusher assembly became bent and broke at the proximal end.Therefore, the smart coil was removed.The procedure was completed using three additional smart coils, three non-penumbra coils, the same microcatheter, the same catheter, and the same guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 136.0 cm from the proximal end.The pusher assembly was fractured approximately 137.5 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was detached from its pusher assembly, inside its introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.If this occurs, resistance may be encountered during advancement, and the smart coil may not advance within its introducer sheath.If the device is forcefully mishandled while advancing against this resistance, damage such as kinks in the pusher assembly may occur.Further manipulation of a kinked device may result in a fracture.Further evaluation of the returned smart coil revealed that the embolization coil was detached from its pusher assembly inside its introducer sheath.This damage was likely incidental to the reported complaint and resulted from the pusher assembly fracturing and the two fracture segments being separated.This resulted in the pull wire being retracted out of the ddt and the coil detaching in the introducer sheath.Penumbra coils are visually 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.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9960491
• MDR Text Key: 187943960
• Report Number: 3005168196-2020-00549
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F86217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1