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	07/20/2021
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2021-01810, 3005168196-2021-01811, 3005168196-2021-01812.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) using packing coil lps, a lp system detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician attempted to detach three packing coil lps using the handle; however, all three packing coil lps failed to detach.The physician also tried using another handle but was unsuccessful.Afterwards, the physician was able to manually detach the packing coil lps after multiple attempts.It was reported that the first handle worked fine while performing a click test; however, while trying to detach the coil, the handle would only half click and slowly return to its original position without detaching the coil.The procedure was completed using five additional packing coil lps and the second handle.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: 12321330
• Report Number: 3005168196-2021-01813
• Device Sequence Number: 4136109
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 08/13/2021
• 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 Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Was Device Available for Evaluation?: No
• 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: 07/20/2021
• Initial Report FDA Received Date: 08/13/2021
• 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