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

Catalog Number	4004J25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
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 numbers: 1.3005168196-2019-01495 2.3005168196-2019-01496.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the dural arteriovenous fistula (davf) using penumbra coils 400 (pc400) and lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed three pc400s in the target vessel using the lantern.While advancing a new pc400 coil in the lantern, the physician experienced resistance approximately five centimeters from the proximal end; therefore, the pc400 removed.During a second attempt to advance the same pc400, resistance was felt; therefore, the pc400 was removed and not used in the procedure.The physician advanced another pc400 against resistance; however, the coil was placed successfully in the target vessel.The physician then decided to remove the lantern.The procedure was completed using a pc400 and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box5.Describe event or problem.Results: the pet lock was intact on the proximal end of its pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned pc400 revealed that the device had offset coil winds.If the pc400 is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, resistance was encountered while advancing the pc400 through the returned lantern and the device was unable to advance past the distal ovalization on the lantern.Further evaluation of the returned pc400 revealed resistance while advancing the returned pc400 through a demonstration lantern and the pc400 could not be advanced any further.The offset coil winds likely contributed to the inability to advance the pc400 through the demonstration lantern.Evaluation of the returned lantern revealed that the distal shaft of the catheter was ovalized.This type of damage typically occurs if the re-useable sheath is not used during insertion of the lantern into a parent device or if the lantern is forcefully pinched or gripped during insertion.During the functional testing, a demonstration pc400 and the returned pc400 were advanced into the returned lantern and were unable to advance past the ovalization in the lantern.The ovalization likely contributed to the resistance experienced during the procedure.Penumbra coils and catheters 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.This report is associated with mfr report number: 1.3005168196-2019-01495 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the dural arteriovenous fistula (davf) using penumbra coils 400 (pc400) and lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed three pc400s in the target vessel using the lantern.While advancing a new pc400 coil in the lantern, the physician experienced resistance approximately five centimeters from the distal end; therefore, the pc400 removed.During a second attempt to advance the same pc400, resistance was felt; therefore, the pc400 was removed and not used in the procedure.The physician advanced another pc400 against resistance; however, the coil was placed successfully in the target vessel.The physician then decided to remove the lantern.The procedure was completed using a pc400 and a new lantern.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8856296
• Report Number: 3005168196-2019-01494
• Device Sequence Number: 16826928
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• 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): 07/04/2019
• 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: 02/20/2024
• Device Catalogue Number: 4004J25
• Device Lot Number: F68025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005