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

Catalog Number	4002C1245
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly had bends approximately 88.0 cm and 97.0 cm from the proximal end.The embolization coil was intact with pusher assembly and the coil was compressed.The distal part of the coil was approximately 1.0 cm out of the introducer sheath and the coil had offset coil winds throughout the length of the coil.Coagulated blood was present at the distal tip of the introducer sheath.Conclusions: evaluation of the returned penumbra coil 400 (pc400) revealed embolization coil damage along its length.If the introducer sheath is not properly aligned in the hub prior to advancement, resistance may be experienced.If the device is advanced against this resistance, the embolization coil will likely become damaged.Resistance will likely be experienced during subsequent attempts to advance or re-sheath the damaged coil.Retracting the damaged coil back into the sheath likely resulted in the compressed coil and exposed sr wire on the proximal end of the coil implant.Further evaluation revealed bends along the length of the pusher assembly.Based on the reported complaint, the bends were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are visually 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a penumbra coils 400s (pc400).During the procedure, the physician successfully placed three pc400 in the target vessel.While attempting to insert a new pc400, the physician experienced resistance at the hub of the microcatheter and the coil would not advance further; therefore, the pc400 was removed.The procedure was completed using a new pc400 and additional coils with the same microcatheter.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: 8169219
• Report Number: 3005168196-2018-02458
• Device Sequence Number: 16483509
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 11/19/2018
• 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: 06/11/2025
• Device Catalogue Number: 4002C1245
• Device Lot Number: F77629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• 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: 11/19/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005