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

Catalog Number 4004C1030

Device Problems Kinked (1339); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00656.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two coils and a pc400 using a non-penumbra microcatheter.The physician then felt resistance while advancing a pc400 through the microcatheter, and therefore the pc400 was removed.It was reported that the pc400 was elongated and kinked.A new pc400 was then successfully placed.The physician then felt resistance advancing another pc400 within the microcatheter, however upon retraction to remove the pc400, the physician found that the pc400 had unintentionally detached within the microcatheter.The physician therefore removed with microcatheter with the pc400 inside, and then reinserted the same microcatheter.The procedure was completed using a new pc400.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the first pc400 evaluated was kinked approximately 107.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and hanging out of the returned introducer sheath.The stretch resistant wire (sr wire) was visible on the distal end of the pusher assembly.A demonstration pc400 was able to advance approximately 10.0 cm into the returned non-penumbra microcatheter before encountering resistance and was unable to be advanced further.Conclusions: evaluation of the returned pc400 coils revealed the embolization coils were detached.The first pc400 was detached via sr wire fracture.This typically occurs during forcefully retraction of the device against resistance.The first pc400 embolization coil was not reported to have been detached.Therefore, the sr wire likely fractured after the procedure and was incidental to the reported malfunction.Further evaluation of the first pc400 revealed the pusher assembly was kinked.This damage was likely incidental to the reported failure and may have occurred during packaging for return to penumbra.Further evaluation of the second pc400 revealed the proximal constraint sphere was missing from ddt.If the device is retracted against a strong resistance the polymer section of the pusher assembly may elongate.If the ddt extends past the pull wire, the proximal constraint sphere may slip out, detaching the embolization coil.The detached embolization coil could not be removed from the returned non-penumbra catheter and, therefore, the root cause of the detachment could not be determined.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.This report is associated with mfr report number: 3005168196-2018-00656.

• 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: 7383804
• MDR Text Key: 103925185
• Report Number: 3005168196-2018-00655
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/01/2005,03/02/2018

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: Physician
• Device Catalogue Number: 4004C1030
• Device Lot Number: F71860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• 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: 03/02/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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