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	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed kinks on the pusher assembly.If the device is forcefully advanced against resistance during the procedure, damage such as this may occur.This damage likely contributed to the device failure to detach during the procedure.During functional testing, the ruby coil lp was unable to detach using the returned handle and a demonstration handle.The device was unable to manually detach as well.Further evaluation of the device revealed that the pet lock was separated, the pull wire was slightly retracted from its alignment feature.This damage was a result of an unsuccessful detachment attempt of the embolization coil during the procedure.Further evaluation also revealed offset coil winds on the embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned ruby coil lp revealed that the pet lock was separated on the proximal end of the pusher assembly and the embolization coil was detached from its pusher assembly.If the pet lock is separated and the pull wire is retracted from the pusher assembly ddt, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed pusher assembly kinks.This damage was likely incidental to the complaint.Evaluation of the returned handle revealed a functional and undamaged device.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration ruby coil lp without issue.Penumbra coils and handles are visually inspected and functionally tested during incoming 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 numbers: 3005168196-2021-00410, 3005168196-2021-00411.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak of the inferior mesenteric artery (ima) and superficial femoral artery (sfa) using ruby coil lps, an lp system detachment handle (handle), a non-penumbra microcatheter, and a 5fr catheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a ruby coil lp into the vessel and attempted to detach it using a handle; however, the ruby coil lp failed to detach even after the alignment zone (pet lock) had separated.Therefore, the ruby coil lp was removed.The physician then advanced a new ruby coil lp to the target location and attempted to detach it using the handle; but the same issue occurred.Therefore, the physician decided to remove the ruby coil lp.However, while retracting the ruby coil lp, the physician noticed the coil had unintentionally detached within the microcatheter under fluoroscopy.Subsequently, the physician attempted to flush the ruby coil lp, but the coil was stuck within the microcatheter.Therefore, the physician attempted to push the ruby coil lp through the microcatheter using the pusher assembly; however, access was lost with the microcatheter and 5fr catheter.Therefore, the microcatheter containing the detached ruby coil lp was removed.The procedure was completed using other coils, a new microcatheter, and the same 5fr catheter.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: 11436845
• Report Number: 3005168196-2021-00412
• Device Sequence Number: 3117378
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/08/2021
• 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: 07/12/2025
• Device Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Device Lot Number: F98815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005