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

Catalog Number	4004C0513
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully advanced five pc400s into the target vessel.While attempting to advance the sixth pc400, it was reported that it would not advance at all within its introducer sheath.The pc400 was then removed and was not used in the procedure.The procedure was completed using three additional pc400s.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 embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 7.0 cm from the distal tip.Conclusions: evaluation of the returned pc400 revealed an ovalized introducer sheath.If the rotating hemostasis valve (rhv) is overtightened on the introducer sheath, damage such as an ovalization may occur.Resistance was encountered while advancing the pc400 through its ovalized sheath and the pc400 could not be advanced any further.The ovalization in the introducer sheath likely prevented the pc400 from being advanced within its sheath.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8489259
• Report Number: 3005168196-2019-00653
• Device Sequence Number: 2689814
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 03/08/2019
• 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: 02/09/2024
• Device Catalogue Number: 4004C0513
• Device Lot Number: F67851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005