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

Catalog Number	4002C2260
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
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 numbers: 3005168196-2019-00997; 3005168196-2019-00999.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance while advancing the first pc400 in the middle of the lantern; therefore, the pc400 was removed.While advancing the second pc400 the same issue occurred and the coil and the lantern were removed.Upon removal, the physician noticed that the lantern was kinked at the shaft.The procedure was then completed using another microcatheter and additional penumbra coils.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 undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusion: evaluation of the returned pc400 revealed a fully functional device.During functional testing, the pc400 was advanced through its introducer sheath and through a demonstration microcatheter without issue.Evaluation of the returned lantern revealed a fracture.This damage is likely the reported kink.If a kinked device is manipulated further, it may become fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Based on the reported complaint, the root cause of the kink was unable to be determined.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 numbers: 3005168196-2019-00997 and 3005168196-2019-00999.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8633728
• Report Number: 3005168196-2019-01000
• Device Sequence Number: 1644239
• Product Code: HCG
• UDI-Device Identifier: 00814548010786
• UDI-Public: 00814548010786
• 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): 04/23/2019
• 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: 11/23/2021
• Device Catalogue Number: 4002C2260
• Device Lot Number: A39791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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