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

Catalog Number	4002C1450
Medical Device Problem Codes	Failure to Fold (1255); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
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 in the gastric varix using penumbra coil 400s (pc400s).During the procedure, the physician advanced a pc400 into the target vessel using a lantern delivery microcatheter (lantern), however, the pc400 would not take its intended shape.The physician then removed the pc400 from the patient and set it aside for later use.A pod12 coil was then successfully advanced into the target vessel using the same lantern.Subsequently, the physician attempted to re-advance the pc400, but reported feeling resistance during advancement.It was also reported that the pc400 would only advance a few centimeters out of its introducer sheath.The pc400 was therefore removed and was no longer used in the procedure.The procedure was completed using four additional pc400s and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 1.Describe event or problem.Results: the pet lock was intact on the proximal end of the pusher assembly.Kinks were present approximately 107.0 and 123.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher distal detachment tip (ddt).The embolization coil had offset coil winds and dried blood was present throughout the introducer sheath.Conclusions: evaluation of the returned pc400 revealed an embolization coil with offset coil winds.If the pc400 is forcefully advanced against resistance, damage such as offset coil winds may occur.These offset coil winds likely contributed to the inability to advance the device.Further evaluation revealed coagulated blood along the length of the device.If blood coagulates on the device, resistance may be experienced during subsequent attempts to advance the device.During functional testing the pc400 was unable to advance from its initial position in the introducer sheath.Evaluation of the returned lantern revealed an undamaged device.A demonstration pc400 was advanced through the lantern without issue.Penumbra catheters and 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric varix using penumbra coil 400s (pc400s).During the procedure, the physician advanced a pc400 into the target vessel using a lantern delivery microcatheter (lantern), however, the pc400 would not take its intended shape.The physician then removed the pc400 from the patient and set it aside for later use.A pod12 coil was then successfully advanced into the target vessel using the same lantern.Subsequently, the physician attempted to re-advance the same pc400, but reported feeling resistance during advancement.It was also reported that the pc400 would only advance a few centimeters from its initial position within the introducer sheath.The pc400 was therefore removed and was no longer used in the procedure.The procedure was completed using four additional pc400s and the same 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: 8370466
• Report Number: 3005168196-2019-00358
• Device Sequence Number: 1098823
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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): 01/28/2019
• 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: 07/17/2026
• Device Catalogue Number: 4002C1450
• Device Lot Number: F84748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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