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

Catalog Number 4002C0935

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

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 left middle cerebral artery (mca) using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance while attempting to advance the first coil, a pc400, through its introducer sheath and was unable to advance the pc400 beyond its starting position.The pc400 was therefore removed and was not used in the procedure.The procedure was completed using another pc400 and the same px slim delivery microcatheter (px slim).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends approximately 12.0 cm, 23.0 cm and 40.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The pet bump on the pull wire was distal to the ddt.The proximal end of the embolization coil was within the introducer sheath.The embolization coil was compressed, and offset coil winds were present along the length of the coil.During functional testing, resistance was encountered while retracting the pc400 into the introducer sheath and the embolization coil became more compressed.Strong resistance was encountered while advancing the pc400 and the device could not advance out of its introducer sheath.Conclusions: evaluation of the returned pc400 revealed offset coil winds.If the introducer sheath is not seated properly within the hub of its parent catheter, resistance may be encountered while advancing.If the device is forcefully advanced against this resistance, damage such as offset coil winds will likely occur.This damage likely contributed to the reported inability to advance the coil during the procedure and functional testing.Further evaluation revealed the pull wire was distal to the ddt.This was also likely a result of forcefully advancing the device against resistance.The bends on the returned device were likely incidental to the reported complaint.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.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8199341
• MDR Text Key: 131505009
• Report Number: 3005168196-2018-02515
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4002C0935
• Device Lot Number: F80570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• 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: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR