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

Catalog Number 4004C1030

Device Problems Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the left subclavian artery using penumbra coils 400s (pc400s).During the procedure, the physician placed two non-penumbra coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a pc400 through the microcatheter, the physician experienced resistance after advancing the pc400 half way through the microcatheter.Subsequently, the pc400 became stuck when it was about to exit the tip of the microcatheter; therefore, microcatheter and pc400 were removed altogether.The procedure was completed using the same microcatheter and four additional pc400s without further issues.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: 7162330
• MDR Text Key: 96827870
• Report Number: 3005168196-2018-00017
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 4004C1030
• Device Lot Number: F79611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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