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

Model Number	4002C2060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 (pc400).During the procedure, while attempting to advance a pc400 into the target vessel, the physician noticed the coil had broken into pieces.Therefore, the physician used a non-penumbra balloon catheter successfully to remove the pc400 fragment.The procedure was completed using new pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that additional information was provided on 10-sep-2019, as this complaint was submitted to the fda by the user facility with the following reference number: (b)(4) 1.Section a.Box 2.Age at time of event and age unit.2.Section a.Box 5a.Ethnicity.3.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a penumbra coil 400 (pc400), a neuron max 6f 088 long sheath (neuron max), two non-penumbra microcatheters and a non-penumbra balloon catheter.During the procedure, a pc400 was placed in the aneurysm.The physician noticed there was significant herniation into the parent vessel lumen due to the wide neck nature of the lesion.Therefore, the physician decided to proceed with pipeline embolization system placement first and the microcatheter that was being used was removed.A different microcatheter was then advanced over an exchange wire; however, the microcatheter abutted the aneurysm ica interface and subsequently, the physician lost access.While attempting to remove the pc400, the coil broke inside the microcatheter.The microcatheter was then removed from the patient.It was reported that the coil extended from the aneurysm down into the abdominal region of the neuron max.The physician then used a balloon catheter to successfully remove the detached pc400 from the patient.It was reported that at one point of the procedure the patient was given an infusion of intra-arterial nitroglycerin for the prevention and treatment of a catheter induced spasm.The location of the spasm as well as the device associated with the spasm is unknown.The procedure was completed using additional pc400s.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8753262
• Report Number: 3005168196-2019-01297
• Device Sequence Number: 19432584
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 4002C2060
• Device Catalogue Number: 4002C2060
• Device Lot Number: F61496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005