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

Catalog Number	4004C1335
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	06/01/2019
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2019-01349.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed a pc400 using a px slim delivery microcatheter (px slim) and neuron 6f 070 delivery catheter (neuron 070).While attempting to advance a new pc400, the physician experienced resistance and the pc400 would not advance within its introducer sheath; therefore, it was removed.It was reported that the same issue occurred with another pc400.The procedure was completed using a new pc400, the same neuron 070 and same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was ovalized at approximately 88.0 cm from its proximal end.Conclusions: evaluation of the first returned pc400 revealed an ovalization on its introducer sheath and offset coil winds along its embolization coil.If the introducer sheath is forcefully gripped or pinched during the procedure, it may become ovalized.Resistance may be encountered while advancing the embolization coil through this ovalization.If the device is forcefully advanced against resistance, the embolization coil winds may become offset.During the functional testing, the device was able to advance through its introducer sheath with some resistance.Evaluation of the second returned pc400 revealed an ovalization on its introducer sheath and offset coil winds on the embolization coil.If the introducer sheath is forcefully gripped or pinched during the procedure, it may become ovalized.Resistance may be encountered while advancing the embolization coil through this ovalization.If the device is forcefully advanced against resistance, the embolization coil winds may become offset.During the functional testing, resistance was encountered while advancing the device and the embolization coil could not be advanced through the ovalized 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.This report is associated with mfr report number: 1.3005168196-2019-01349 h3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8780549
• Report Number: 3005168196-2019-01348
• Device Sequence Number: 2014475
• Product Code: HCG
• UDI-Device Identifier: 00814548011035
• UDI-Public: 00814548011035
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 06/11/2019
• 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: 08/05/2026
• Device Catalogue Number: 4004C1335
• Device Lot Number: F85122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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