MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4002C1040

Device Problems Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked in multiple locations and fractured approximately 83.0 cm from the proximal end, with the pull wire withdrawn out of the distal segment.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed that the pusher assembly was kinked in multiple locations and fractured, and that the embolization coil was detached.Since the pc400 was reportedly removed from the procedure with no mention of fracture or detachment, the fracture was likely incidental.The observed fracture and some of the observed kinks may have occurred during packaging for return.If the pusher assembly becomes fractured, it may allow the pull wire to retract out of the distal detachment tip (ddt), which would allow the embolization coil to detach.Since the pc400 could not be functionally tested for advancement through a microcatheter due to the fracture and detached embolization coil, the root cause of the issues experienced during the procedure could not be determined.Due to the multiple kinks located throughout the pusher assembly, the kink that occurred while pushing and pulling the pc400 could not be identified.The pc400 introducer sheath and the px slim mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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: 3005168196-2017-02130.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400's (pc400's) and a px slim delivery microcatheter (px slim).During the procedure, the physician placed the px slim into the distal end of the right iia (superior gluteal artery and bifurcation of inferior gluteal artery), then deployed and detached six pc400's into the target vessel.While attempting to advance a new pc400 through the px slim, the physician experienced resistance when the coil was advanced midway through the px slim.Subsequently, the pc400 pusher assembly became kinked when the physician used a little force in an attempt to advance the coil further.Therefore, the physician removed both the px slim and the pc400 from the patient¿s body.The procedure was then completed using a new px slim and three additional pc400''s.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• 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: 7089265
• MDR Text Key: 95072147
• Report Number: 3005168196-2017-02129
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2017

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: Physician
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 4002C1040
• Device Lot Number: F68188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• 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: 81 YR