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

Model Number	4002C2260
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an aneurysm in a collateral segment vessel connecting renal, splenic, and portal veins using penumbra coil 400s (pc400s), non-penumbra coils, non-penumbra vascular plug, a non-penumbra microcatheter, a non-penumbra diagnostic catheter, and a non-penumbra sheath.During the procedure, the physician placed two pc400s distal to the aneurysm using the microcatheter.It was reported that a vascular plug was placed but not detached.Then, the physician placed two non-penumbra coils proximal to the aneurysm.Afterwards, while the physician advanced another pc400 through the microcatheter distal to the aneurysm, the pc400 unintentionally detached inside the microcatheter.It was reported that the proximal end of the pc400 was inside the microcatheter and the distal end of the pc400 was inside the vessel.Subsequently, the detached pc400 was removed with difficulty using a pusher wire of a vascular plug and the microcatheter was also removed.The procedure was completed by placing a vascular plug.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12530551
• Report Number: 3005168196-2021-02115
• Device Sequence Number: 17201290
• Product Code: HCG
• UDI-Device Identifier: 00814548010786
• UDI-Public: 00814548010786
• 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): 09/24/2021
• 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: 4002C2260
• Device Catalogue Number: 4002C2260
• Device Lot Number: F103261
• 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: 09/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005