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

Catalog Number	4006C0204
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 111.0 cm and 131.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The embolization coil had offset coil winds on the distal tip and coagulated blood.Conclusions: evaluation of the returned pc400 revealed that the embolization coil had offset coil winds.These offset coil winds likely contributed to the difficulty advancing the pc400 within its sheath.This type of damage typically occurs if embolization coil is forcefully advanced against resistance.The root cause of the initial resistance could not be determined.Further evaluation of the returned pc400 revealed that the distal tip of the embolization coil had coagulated blood on it.If an rhv is not used during the procedure, it is likely that the blood will backflow into the sheath and coagulate on the device.During functional testing, the pc400 was able to be advanced out of its introducer sheath with some resistance as the offset coil winds with coagulated blood exited the distal tip of the introducer sheath.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra 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 internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician experienced resistance after advancing the pc400 approximately three centimeters into the introducer sheath; therefore, the pc400 was removed.The physician then attempted to insert the same pc400 without using the rotating hemostasis valve (rhv); however, experienced resistance in the same area.Therefore, the pc400 was removed.The procedure was completed using a new pc400 with the same lantern delivery microcatheter (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: 8255493
• Report Number: 3005168196-2019-00106
• Device Sequence Number: 2125274
• Product Code: HCG
• UDI-Device Identifier: 00814548011783
• UDI-Public: 00814548011783
• 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
• Report Date (Section B): 12/18/2018
• 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: 07/18/2026
• Device Catalogue Number: 4006C0204
• Device Lot Number: F84756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005