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	07/10/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coils 400 (pc400s).During the procedure, the physician successfully placed two pc400s in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a third pc400 over the hub of the lantern, the physician experienced resistance; therefore, the physician flushed the lantern and the pc400.However, resistance was encountered again when trying to re-advance the pc400; therefore, the pc400 was removed.It was reported that the blood clot may have been attached to the pc400.The procedure was completed using four other pc400s and the same lantern.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 penumbra coils 400 (pc400) pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.Coagulated blood was present inside the introducer sheath.Conclusions: evaluation of the returned pc400 revealed offset coil winds along the length of the embolization coil.If the introducer sheath is not properly aligned inside the hub of the lantern prior to advancement, resistance may be encountered.If the device is forcefully advanced against the resistance, damage such as offset coil winds may occur.Further investigation revealed coagulated blood was inside the introducer sheath.This damage was likely incidental to the complaint.Evaluation of the returned lantern revealed an undamaged device.The complaint indicated that the lantern was used to finish the procedure.There were no allegations against the lantern.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8972026
• Report Number: 3005168196-2019-01695
• Device Sequence Number: 2471144
• 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): 08/08/2019
• 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: 12/25/2025
• Device Catalogue Number: 4002C1450
• Device Lot Number: F81165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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