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

Catalog Number	4002C1660
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	04/05/2019
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.This report is associated with mfr report number: 3005168196-2019-00959.
Event or Problem Description
The patient was undergoing a coil embolization procedure in renal artery using penumbra coils 400s (pc400).During the procedure, the physician placed a pc400 in the target vessel using a lantern delivery microcatheter (lantern) and a non-penumbra guide catheter.While attempting to advance a new pc400 into the microcatheter, the physician experienced resistance and the pc400 would not advance within its introducer sheath; therefore, it was removed.The physician then attempted to advance another pc400 into the microcatheter, but the same issue occurred; therefore, it was removed.The procedure was completed using new pc400s with the same lantern and guide catheter.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 and had offset coil winds.The introducer sheath was ovalized at approximately 7.0 cm from the distal end.Conclusions: evaluation of the returned pc400s revealed ovalizations on their introducer sheaths, near the distal tip.If the rotating hemostasis valve (rhv) used in the procedure is overtightened while introducer sheath is inserted, the introducer sheath may become pinched and ovalized within the rhv.This ovalization likely contributed to the reported resistance while advancing device.During functional testing, resistance was encountered at the ovalizations while advancing the devices and embolization coils could not be advanced out of their introducer sheaths.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.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8610108
• Report Number: 3005168196-2019-00958
• Device Sequence Number: 19335506
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• 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,Followup
• Report Date (Section B): 04/16/2019
• 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: 04/15/2026
• Device Catalogue Number: 4002C1660
• Device Lot Number: F82876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 78
• Date Report Sent to FDA: 01/01/2005