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

Model Number	4002C0935
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400s).During the procedure, the physician implanted five coils in the target location.Subsequently, the physician found the pusher assembly of a pc400 was damaged while removing it from the dispenser hoop.The physician then inserted the introducer sheath into hub of the microcatheter and attempted to push the pusher assembly of the pc400 into the rotating hemostasis valve (rhv); however, resistance was encountered, and the pusher assembly of the pc400 broke in two pieces.Therefore, the pc400 was removed.The procedure was completed using a new pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 42.0 cm from the proximal end.The pusher assembly was kinked approximately 79.0 cm and 120.0 cm from its proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned pc400 pusher assembly confirmed a fracture.If the device is forcefully advanced against resistance during use, damage such as a kink and subsequent fracture may occur.The complaint reported that the pusher assembly was damaged while retracting from its packaging hoop.This damage may have contributed to the reported resistance and the pusher assembly fracture during the procedure.Further evaluation of the device revealed kinks on the pusher assembly, and the embolization coil was detached from the pusher assembly.This damage was likely incidental to the 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.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11015800
• Report Number: 3005168196-2020-02277
• Device Sequence Number: 3944496
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• 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): 11/18/2020
• 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: 4002C0935
• Device Catalogue Number: 4002C0935
• Device Lot Number: F97401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005