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

Catalog Number 4002C1450

Device Problems Failure to Advance (2524); Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

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 in the right internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician experienced resistance while advancing a pc400 in the hub of a lantern delivery microcatheter (lantern).Another unsuccessful attempt was made to advance the pc400 into the lantern; therefore, the pc400 was removed and not used in the procedure.The physician completed the procedure using four other coils and the same lantern.It was noted that the physician found an unknown wire coming from the coil.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal of its pusher assembly.The embolization coil was intact with its pusher assembly and the pull wire was distal to the distal detachment tip (ddt).Conclusions: evaluation of the returned pc400 revealed that the pull wire was advanced distal to the ddt.If the device is forcefully advanced against resistance, damage such as this may occur.During the functional test, the pc400 was advanced out of its introducer sheath with resistance as the coil began to snake within its sheath.The pc400 was then advanced through a demonstration microcatheter without an issue.Resistance was experienced while attempting to advance the pc400 through the returned lantern and, consequently, the distal tip of the pc400 embolization coil became kinked and the pc400 could not be advanced any further.The root cause of the initial resistance could not be determined.Evaluation of the returned lantern revealed that the device was functional.During the functional test, a demonstration coil was advanced through the returned lantern and out of the distal tip without an issue.Penumbra coil and catheters 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.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8780559
• MDR Text Key: 150710059
• Report Number: 3005168196-2019-01347
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4002C1450
• Device Lot Number: F77076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• 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: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1