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

Model Number	4004C1335
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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 to treat dural arteriovenous fistulas (davfs) using penumbra coil 400s (pc400s).During the procedure, a pc400 would not advance at all within its introducer sheath; therefore, it 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Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was retracted through the introducer sheath friction lock.The introducer sheath was stretched on the pusher assembly distal shaft and the sr wire was visible over the stretched region.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the introducer sheath was stretched at the distal tip of the pusher assembly and the proximal end of the embolization coil.If the introducer sheath is stretched, it will likely deform resulting in resistance on subsequent attempts to manipulate the pusher assembly.Based on the returned condition, the root cause of the reported complaint could not be determined.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.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: 9849483
• Report Number: 3005168196-2020-00380
• Device Sequence Number: 13644475
• Product Code: HCG
• UDI-Device Identifier: 00814548011035
• UDI-Public: 00814548011035
• 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): 02/26/2020
• 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 Expiration Date: 03/01/2023
• Device Model Number: 4004C1335
• Device Catalogue Number: 4004C1335
• Device Lot Number: C10354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005