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	10/28/2021
Type of Reportable Event	Malfunction
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.This report is associated with mfr report numbers: 3005168196-2021-02658, 3005168196-2021-02659.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hypogastric and other feeders from profunda artery using ruby coil lps and lp system detachment handle (handle).It should be noted that the patient's vessel was very small and tortuous.During the procedure, the physician advanced a ruby coil lp in the target location and attempted to detach it using the handle; however, the ruby coil lp failed to detach after multiple attempts.It was reported that the black alignment zone on the ruby coil lp was separated by approximately 5mm but the ruby coil lp would not detach.The physician also attempted to manually detach the ruby coil lp but was unsuccessful.Therefore, the ruby coil lp was removed.Next, the physician advanced another ruby coil lp and attempted to detach it using the same handle but the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp.Afterwards, the physician advanced another ruby coil lp; however, a vessel spasm occurred and therefore, the ruby coil lp was removed.It was reported that the vessel spasm was not directly related to the ruby coil lp and was considered resolved.It was also reported that three ruby coil lps were detached in another vessel using the same handle before encountering the issue.The physician decided to end the procedure.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12858139
• Report Number: 3005168196-2021-02660
• Device Sequence Number: 14476521
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021
• 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: 06/07/2026
• Device Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Device Lot Number: F106886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/28/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: 27 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005