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

Model Number 4006U0203

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400s (pac400) and non-penumbra microcatheters.During the procedure, it was reported that the pac400 would not deploy.Therefore, it was removed.It is unknown how the procedure was completed or if there was any adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pac400 revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kinks near the mid-joint.Further evaluation revealed dried blood within the introducer sheath distal tip.This damage was likely incidental to the reported complaint.During functional testing, the pac400 was unable to be advanced at all from its returned position within the introducer sheath.Penumbra coils 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.

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400) and non-penumbra microcatheters.During the procedure, it was reported that the pc400 would not deploy.Therefore, it was removed.It is unknown how the procedure was completed or if there was any adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 1.Section b.Box 5.Describe event or problem.2.Section d.Box 1.Brand name 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: 11681897
• MDR Text Key: 249660880
• Report Number: 3005168196-2021-00772
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548011363
• UDI-Public: 00814548011363
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4006U0203
• Device Catalogue Number: 4006U0203
• Device Lot Number: F89903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1