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	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no visible damage to the handle.The handle was attempted to be functionally tested using a handle fixture (an3277 / fx2817) for pull force and throw distance.However, the handle did not seat properly on the fixture.The nose cone was removed to evaluate the issue and it was noticed that the nose cone was damaged.The inner diameter (id) of the nose cone has a specification of 0.018¿ +0.000¿/-0.002¿.Pin gauges were used to measure the id and a 0.020¿ pin gauge was able to advance through.A demonstration handle was used as reference for where the nose cone should be seated on the fixture.There was a damaged nose cone seated on the fixture.Conclusion: evaluation of the returned handle revealed a damaged device.The id of the nose cone was larger than specification.If a pusher assembly is forcefully seated inside the nose cone, it may bore the id of the nose cone hole open.This is further supported by the shaved material on the inner side of the nose cone hole.This damage likely prevented the handle from seating properly, contributing to the reported failure to detach.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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: 3005168196-2019-00147.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using a pod detachment handle (handle) and a pod coil.During the procedure, the physician successfully placed the pod coil in the target vessel; however, was unable to detach the coil using the handle.A new handle was used to successfully detach the coil, and the procedure was then completed using additional coils and the new handle.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using a pod detachment handle (handle) and a pod6.During the procedure, the physician successfully placed the pod6 in the target vessel; however, was unable to detach the coil using the handle.A new handle was used to successfully detach the pod6, and the procedure was then completed using additional coils and the same new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The following section is being updated based on additional information provided by the distributor on 03/28/2019: describe event or problem.This report is associated with mfr report number: 3005168196-2019-00147.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using a penumbra coil 400 detachment handle (handle) and a pod6.During the procedure, the physician successfully placed the pod6 in the target vessel; however, was unable to detach the coil using the handle.A new handle was used to successfully detach the pod6, and the procedure was then completed using additional coils and the same new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up mfr report #1 and is being corrected on this follow-up mfr report#2: section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2019-00147.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8276495
• Report Number: 3005168196-2019-00145
• Device Sequence Number: 19320861
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024
• 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: 06/25/2021
• Device Catalogue Number: DH1
• Device Lot Number: F84314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 03/28/2019; 01/14/2005
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/26/2019; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 01/01/2005