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

Catalog Number 4004C0513

Device Problems Failure to Advance (2524); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400).The pusher assembly was kinked approximately 5.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured.The embolization coil was inside its introducer sheath.The sr wire was fractured and, therefore, both the pc400 was unable to be functionally tested for the ability to track inside a microcatheter.Conclusions: evaluation of both returned pc400s revealed that their sr wires were fractured.This type of damage typically occurs due to forceful retraction of the embolization coil against resistance.If the sr wire fractures, it will result in the unintentional detachment of the embolization coil.Further evaluation of both returned pc400s revealed that their pusher assemblies were kinked.These kinks were likely incidental and may have occurred while packaging the devices for return to penumbra.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2017-02255.

Event Description

The patient was undergoing a coil embolization procedure in the superior gluteal artery using penumbra coil 400''s (pc400's).It was noted that the patient had slight calcification.During the procedure, the physician deployed and detached four initial pc400's into the target vessel using a px slim delivery microcatheter (px slim).While attempting to advance two new pc400's into the px slim, the physician connected the introducer sheath with the hub of the px slim and advanced the coils approximately twenty to thirty centimeters into px slim.The physician then felt scratching and was unable to advance the pc400's further.It was also reported that one of the pc400's unintentionally detached within the px slim.Therefore, the px slim containing the detached pc400 was removed, then the detached coil was removed from the px slim.Thereafter, the procedure was completed using the same px slim and fourteen new pc400s.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: 7139693
• MDR Text Key: 95911580
• Report Number: 3005168196-2017-02256
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 4004C0513
• Device Lot Number: F73405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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