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

Catalog Number	4004J25
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	07/17/2018
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.This report is associated with mfr report number: 3005168196-2018-01594.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the sinus transversus using penumbra coils 400 (pc400s).During the procedure, the physician placed seven coils in the target vessel using a px slim delivery microcatheter (px slim).The physician then advanced a new pc400 into the target vessel but did not like the coil position; therefore, it was removed.While attempting to re-introduce the same pc400, resistance was encountered and subsequently, the pc400 would not advance into the px slim; therefore, it was removed.It reported that the physician did not rinse the pc400 in saline prior to re-using it.Next, the physician successfully deployed and detached another pc400 in the target vessel using the same px slim.The physician then attempted to advance a new pc400 into the px slim but the pc400 would not advance out of its introducer sheath; therefore, it was removed.The procedure was completed using eight additional pc400s 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.Embolization coil was intact to the distal detachment tip of the pusher assembly.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the first pc400 revealed a device with offset coil winds.If the introducer sheath is not properly aligned with the hub of the parent device, resistance may be experienced when advancing the device.If the pc400 is forcefully advanced while experiencing resistance, damage such as offset coil winds may occur.The offset coil winds may have contributed to the reported inability to advance into the px slim.Evaluation of the second pc400 revealed a device capable of advancing out of its introducer sheath.The device was undamaged.During functional testing, the pc400 was able to advance out of its introducer sheath and through a demonstration px slim microcatheter.The reported inability to advance out of its introducer sheath was unable to be confirmed.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.This report is associated with mfr report number: 3005168196-2018-01594.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7785829
• Report Number: 3005168196-2018-01593
• Device Sequence Number: 1986016
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• 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): 07/17/2018
• 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: 04/08/2025
• Device Catalogue Number: 4004J25
• Device Lot Number: F75498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005