MAUDE Adverse Event Report: PENUMBRA, INC. LP SYSTEM DETACHMENT HANDLE; HCG, KRD

Model Number	RLPH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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: 3005168196-2021-01610, 3005168196-2021-01611, 3005168196-2021-01612.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortic sac using ruby coil lps, lp system detachment handles (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp to the target vessel using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp.Next, the physician advanced a new ruby coil lp to the aneurysm sac and attempted to detach it using a new handle, but the ruby coil lp failed to detach.It was reported that the ruby coil lp did not detach even though the black segment on the back of the pusher assembly was separated into two black lines.Therefore, the physician attempted to manually detach the ruby coil lp; however, it was unsuccessful.It was also reported that the pusher assembly was snapped a couple more times, but the coil still did not detach.Therefore, the ruby coil lp was removed.An angiogram was performed and showed that the endoleak had stopped and no further coiling was needed; therefore, the procedure was completed at this point.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 a penumbra sales representative on (b)(6)2021: 1.Section b.Box 5.Describe event or problem evaluation of the first returned handle revealed a functional device.During the functional test, the handle was tested on a handle fixture and passed within specification.The handle was then used to detach a demonstration coil without an issue.Evaluation of the second returned handle revealed a functional device.During the functional test, the handle was tested on a handle fixture and passed within specification.The handle was then used to detach a demonstration coil without an issue.Both ruby coil lps mentioned in the complaint were not returned for evaluation.Therefore, the root cause could not be determined.The returned non-penumbra coil was detached from its delivery wire and had offset coil winds.Penumbra handles are visually inspection and functionally tested during incoming inspection by quality.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: 1.3005168196-2021-01610 2.3005168196-2021-01611 3.3005168196-2021-01612 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortic sac using ruby coil lps, lp system detachment handles (handle), a non-penumbra coil and a non-penumbra microcatheter.During the procedure, the physician advanced a non-penumbra coil to the target vessel using the microcatheter and attempted to detach it; however, the non-penumbra coil failed to detach.Therefore, the physician removed the non-penumbra coil.The physician then advanced a ruby coil lp to the target vessel using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp.Next, the physician advanced a new ruby coil lp to the aneurysm sac and attempted to detach it using a new handle, but the ruby coil lp failed to detach.It was reported that the ruby coil lp did not detach even though the black segment on the back of the pusher assembly was separated into two black lines.Therefore, the physician attempted to manually detach the ruby coil lp; however, it was unsuccessful.It was also reported that the pusher assembly was snapped a couple more times, but the coil still did not detach.Therefore, the ruby coil lp was removed.An angiogram was performed and showed that the endoleak had stopped and no further coiling was needed; therefore, the procedure was completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: LP SYSTEM DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12201077
• Report Number: 3005168196-2021-01609
• Device Sequence Number: 17253487
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 08/05/2021
• 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: 01/24/2026
• Device Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Device Lot Number: F103488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005