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

Catalog Number	4002C0935
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8199341
• Report Number: 3005168196-2018-02515
• Device Sequence Number: 16188928
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2025
• 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005