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

Catalog Number	4006C0408
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
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: 3005168196-2019-01259.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two pc400s in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400, the physician experienced strong resistance at the hub of the microcatheter.Therefore, the physician decided to remove the pc400; however, while retracting the pc400, it unintentionally detached.The physician was able to successfully remove the detached pc400.Next, the physician introduced the same lantern and attempted to advance a new pc400; however, experienced resistance at the hub of the microcatheter.Therefore, the pc400 was removed.The procedure was completed using additional pc400¿s, other coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra distributor on 07/02/2019: results: the pet lock was intact on the proximal end of the pusher assembly.Bends were present on the pusher assembly approximately 60.0, 84.0 and 109.0cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The pusher assembly ddt was fractured.Offset coil winds were present along the embolization coil.The introducer sheath was ovalized approximately 2.5 cm from the distal end.Conclusions: evaluation of the first returned pc400 pusher assembly revealed a fractured pusher assembly and detached embolization coil.If the device is forcefully mishandled while advancing or retracting against resistance, damage such as a fractured pusher assembly ay occur.If the pusher assembly fractures, the pull wire may retract out of the pusher assembly ddt causing the embolization coil to release.The embolization coil was not returned for evaluation.Further evaluation revealed pusher assembly bends.Based on the reported complaint, all the observed damages were likely incidental to the reported complaint; therefore, the root cause of the difficulty advancing could not be determined.Evaluation of the second returned pc400 revealed an embolization coil with offset coil winds.If the introducer sheath is not aligned properly within the hub of its parent catheter, the embolization coil may begin to take shape within the hub and resistance may be experienced during advancement.If the pc400 is advanced against resistance, damage such as offset coil winds may occur.Further evaluation revealed a fractured pusher assembly ddt, pusher assembly bends and an ovalized introducer sheath.If the pc400 is forcefully retracted against resistance, damage such as a fracture may occur.The pusher assembly bends and ovalized introducer sheath were likely incidental to the complaint and may have occurred during packaging for return to penumbra.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: 3005168196-2019-01259.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400).During the procedure, the physician successfully placed two pc400s in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400, the physician experienced strong resistance at the hub of the microcatheter.Therefore, the physician removed the pc400 completely intact.The physician then attempted to advance a new pc400; however, resistance was encountered again.Therefore, the pc400 was removed.The procedure was completed using additional pc400¿s, other coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8745660
• Report Number: 3005168196-2019-01260
• Device Sequence Number: 19204629
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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): 05/30/2019
• 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: 07/18/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F78240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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