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

Catalog Number	4002C2060
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	03/21/2019
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 encountered resistance and was unable to advance a pc400 from its initial position within its introducer sheath.The pc400 was therefore removed and was not used in the procedure.The procedure was completed using another pc400 coil and the same px slim.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 mid-joint was slightly proximal to the introducer sheath friction lock.The friction lock was wrinkled.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned pc400 revealed the pusher assembly mid-joint was proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath which allows it to seat properly on the mid-joint.If the mid-joint is moved proximal to the friction lock, resistance may be experienced during advancement.During functional testing, the introducer sheath was reseated onto the mid-joint.Subsequently, the pc400 was advanced through its introducer sheath and a demonstration microcatheter without issue.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8549296
• Report Number: 3005168196-2019-00818
• Device Sequence Number: 18922562
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 03/28/2019
• 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: 09/16/2023
• Device Catalogue Number: 4002C2060
• Device Lot Number: F65729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005