MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400 DETACHMENT HANDLE; HCG, KRD

Model Number	DH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
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: 3005168196-2021-01050.3005168196-2021-01052.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400s (pc400s), a penumbra coil 400 detachment handle (handle), and a non-penumbra microcatheter.During the procedure, while attempting to detach a pc400 using the handle, the coil alignment zone separated but the coil did not detach.It was reported that the click of the handle was not audible.The physician then made another attempt to detach the pc400 using the handle; however, the pusher assembly of the pc400 became stuck in the handle.Therefore, the physician manually detached the pc400.Next, the physician successfully detached another pc400 in the target vessel using another handle.Then, while attempting to advance the next pc400 through the microcatheter, the pc400 unintentionally detached and became stuck in the microcatheter.Therefore, the microcatheter containing the detached pc400 was removed from the patient.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11828683
• Report Number: 3005168196-2021-01051
• Device Sequence Number: 1058677
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021
• 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: 10/26/2023
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F101508
• 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: 04/19/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005