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

Model Number 4002C1557

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

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 using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 through a px slim.However, it was noticed under fluoroscopy that the pc400 did not exist through the distal tip of the px slim.Therefore, the physician removed the pc400 and re-sheathed it.Afterwards, on the back table, the physician attempted to advance the pc400 but only the pusher assembly of the pc400 was found.The procedure was completed using another pc400.There was no report of adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pc400 revealed that the pull wire was advanced distal to the pusher assembly ddt.If the device is forcefully advanced against resistance, damage such as this may occur.This damage likely contributed to the embolization coil to detach from the pusher assembly during the procedure.The detached embolization coil 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.H3 other text: placeholder.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11935420
• MDR Text Key: 254297440
• Report Number: 3005168196-2021-01245
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/10/2021

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 Model Number: 4002C1557
• Device Catalogue Number: 4002C1557
• Device Lot Number: C24336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• 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: 05/10/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR