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

Catalog Number	DH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
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: 3005168196-2019-01820.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery to treat a type ii endoleak using a penumbra coil 400 (pc400) and penumbra coil 400 detachment handle (handle).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a pc400 through a non-penumbra microcatheter and into the abdominal aortic aneurysm (aaa) sac through the target vessel.The physician then made four attempts to detach the pc400 using the handle but was unable to do so.Subsequently, the physician attempted to manually detach the pc400 but also was unable to do so.While retracting the pc400, it unintentionally detached within the microcatheter; therefore, the microcatheter containing the detached pc400 was removed, and the pc400 was flushed out.The procedure was completed using two other coils, the same microcatheter, and n-butyl cyanoacrylate (nbca) injection.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the handle had a piece of the proximal end of a pusher assembly stuck inside the nosecone.The handle was functionally tested on a handle fixture (an-3277, fx-2817) and performed within specification.Conclusions: evaluation of the returned pc400 revealed that the ddt was fractured off its pusher assembly and intact with the embolization coil proximal constraint sphere.If the device is forcefully retracted against resistance, damage such as this may occur.The non-penumbra microcatheter identified in the complaint and the pc400 pusher assembly were not returned for evaluation and, therefore, the root cause of resistance could not be determined.The reported patient¿s tortuous anatomy may have contributed to the resistance during retraction.Evaluation of the returned handle revealed that the proximal end of a pusher assembly was stuck inside the nosecone.If the handle is actuated multiple times during an attempt to detach a coil, damage such as this may occur.The proximal end of the pusher assembly was removed from the nosecone.The handle was tested on a handle fixture and performed within specification.The patient tortuous anatomy may have contributed to the initial detachment issue prior to the pc400 becoming detached from its pusher assembly.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and 100% functionally tested during in-process 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: 3005168196-2019-01820.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9117688
• Report Number: 3005168196-2019-01821
• Device Sequence Number: 16740165
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• 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): 08/29/2019
• 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: 10/17/2021
• Device Catalogue Number: DH1
• Device Lot Number: F86542
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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