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

Catalog Number	4002C1040
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
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: 3005168196-2019-01729.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed four pc400¿s in the superior gluteal artery using a lantern.It was also reported that the physician managed to advance the four pc400¿s against resistance in the lantern.While attempting to advance a new pc400 as the fifth coil, the physician experienced strong resistance at the end of the microcatheter and decided to detach the coil.The physician then attempted to push out the pc400 using a non-penumbra guidewire and flushing the microcatheter, however, was unsuccessful.Therefore, the lantern was removed with the pc400 inside.The procedure was completed using new pc400¿s and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pc400 pusher assembly was fractured and the total length of the returned pusher assembly was approximately 106.0 cm.The proximal fractured portion of the pusher assembly, pull wire and embolization coil were not returned for evaluation.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was fractured, and the embolization coil was detached.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.The embolization coil was reported to have been detached during the procedure.The proximal fractured portion of the pusher assembly and the embolization coil were not returned for evaluation.Evaluation of the returned lantern revealed damaged coil winds inside the catheter.These damaged coil winds likely contributed to the reported resistance experienced during advancement of the pc400s through the catheter.During the functional testing, a test mandrel was unable to advance through the damaged location of the catheter.The root cause of the damaged coil winds could not be determined.Penumbra coils and catheters 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: 3005168196-2019-01729.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8978047
• Report Number: 3005168196-2019-01728
• Device Sequence Number: 311281
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K152840
• 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): 08/12/2019
• 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: 12/29/2023
• Device Catalogue Number: 4002C1040
• Device Lot Number: F67130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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