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

Model Number	4002C1145
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	03/20/2021
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 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 a right internal carotid artery (ica) carotid-cavernous fistula (ccf) using penumbra coils 400 (pc400), a px slim delivery microcatheter (px slim) and a non-penumbra guiding catheter).During the procedure, the physician accessed the target location with a guide catheter.Next, the physician placed four pc400s into the target location using the px slim.Then, while advancing the fifth pc400 midway through the microcatheter, the pc400 became stuck.Subsequently, the pc400 unintentionally detached, with the distal end of the pc400 entangled in the coil mass and the proximal end of the pc400 detached within the px slim.To prevent disturbing the coil mass, the physician decided to leave the fifth pc400 in the ica.Afterwards, a vessel sacrifice was planned and since the crossflow from the left ica had good flow, another pc400 was placed in the ica.Subsequently, the vessel was sacrificed successfully.The procedure was completed by placing another pc400 to pack the ica tightly.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: 11681510
• Report Number: 3005168196-2021-00770
• Device Sequence Number: 19688935
• Product Code: HCG
• UDI-Device Identifier: 00814548010625
• UDI-Public: 00814548010625
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• 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 Model Number: 4002C1145
• Device Catalogue Number: 4002C1145
• Device Lot Number: F101286
• 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: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Date Report Sent to FDA: 01/01/2005