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

Catalog Number	4002C1450
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	01/07/2019
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.This report is associated with mfr report number: 3005168196-2019-00272.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician placed a non-penumbra guide catheter and a lantern in the target vessel.While inserting the pc400 in the lantern, the physician experienced resistance, and the pc400 became stuck and would not advance further; therefore, the lantern and pc400 were removed.The procedure was completed using a px slim delivery microcatheter and a new pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was damaged but intact at the proximal end of the pusher assembly.Bends and kinks were present along the length of the pusher assembly.The introducer sheath was damaged approximately 88.5 cm and 102.5 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The proximal end of the embolization coil was stuck in the introducer sheath distal tip.The embolization coil had offset coil winds and was hanging out of the introducer sheath.Conclusions: evaluation of the returned pc400 revealed offset coil winds along its length.If the introducer sheath is not properly aligned with the hub of the parent device, resistance may be experienced when attempting to advance the pc400.If the pc400 is forcefully advanced against resistance, offset coil winds may occur.The embolization coil was returned unprotected by the introducer sheath within the rhv.If the embolization coil is manipulated within the rhv without the protective introducer sheath, additional embolization coil damage is likely to occur.Further evaluation revealed damage on the introducer sheath and kinks on the pusher assembly.Based on the return condition, these damages were likely incidental to the complaint.Evaluation of the returned lantern revealed a proximal kink.During functional testing, a demonstration pc400 was able to advance through the lantern without issue.Based on the reported complaint and the functional testing, the kink was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils and catheters 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: 1.3005168196-2019-00272.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8344612
• Report Number: 3005168196-2019-00273
• Device Sequence Number: 1915810
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019
• 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: 11/14/2025
• Device Catalogue Number: 4002C1450
• Device Lot Number: F80573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005