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

Model Number	4002C3260
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-00343, 3005168196-2021-00344, 3005168196-2021-00345.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) using penumbra coils 400 (pc400s), a reused px slim delivery microcatheter (px slim) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing a pc400 (32mm x 60cm) through a reused px slim, the physician experienced resistance and subsequently the pc400 unintentionally detached inside the px slim.Therefore, the detached pc400 was removed using a balloon catheter and the physician also removed the px slim.Next, the physician placed another pc400 in the target location successfully using a new px slim.Next, while advancing another pc400 (28mm x 60cm) to the target location, the physician experienced resistance and subsequently, the pc400 unintentionally detached with half of the pc400 in the target location and the other half of the pc400 in the px slim.The physician was unable to remove the detached pc400 due to the pc400 being tangled with the previous placed pc400.Therefore, the detached pc400 was left in the patient¿s vessel.Afterwards, while advancing another pc400 (24mm x 57cm) to the target location, the pc400 stretched.Subsequently, the pc400 unintentionally detached in the aneurysm and was left in the patient¿s vessel.Then, while advancing another pc400 (18mm x 57cm) to the parent vessel occlusion, the physician experienced resistance.Subsequently, the pc400 unintentionally detached outside the target vessel and was left in the patient¿s vessel.The procedure was completed using another pc400, the same px slim, and the same neuron max without any issues and good closure was achieved from the arterial side.There was no report of an adverse effect to the patient.It was also reported that the patient suffered a cardiac arrest and expired on (b)(6) 2021.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed a detached embolization coil.Further evaluation revealed that the pusher assembly was fractured, and the proximal fractured segment along with the pull wire were not returned for evaluation.If the pc400 is manipulated at extreme angles during use, damage such a kinked and fractured pusher assembly may occur.If the pusher assembly fractures, the embolization coil will likely detach.Further evaluation also revealed additional pusher assembly kinks and offset coil winds on the embolization coil.This damage was likely incidental to the reported complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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: 1.3005168196-2021-00343.2.3005168196-2021-00344.3.3005168196-2021-00345.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11377652
• Report Number: 3005168196-2021-00342
• Device Sequence Number: 3996474
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4002C3260
• Device Catalogue Number: 4002C3260
• Device Lot Number: F100482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005