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

Catalog Number	4004C0513
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pc400 embolization coil was stuck inside the lantern lumen.The proximal constraint sphere was not present on the proximal end of the pc400 embolization coil.Conclusions: evaluation of the returned lantern revealed that the catheter was kinked and ovalized.Further evaluation revealed that the pc400 identified in the complaint was stuck inside the lantern.If the lantern is forcefully advanced through a tortuous anatomy, damage such as a kink and ovalization may occur.The kink and ovalization likely contributed to the resistance experienced while advancing the guidewire and subject pc400 into the lantern.If a coil is advanced through an ovalized catheter, it may become stuck inside the catheter ovalization.If the coil is then forcefully retracted against resistance, it may result in the coil detaching within the catheter.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: 3005168196-2018-01438.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using penumbra coils 400 (pc400s) and a lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was slightly tortuous.During the procedure, the physician advanced a non-penumbra catheter toward the internal iliac artery of the contralateral side from the femoral artery.While advancing a guidewire through a lantern, the physician experienced resistance approximately 30 centimeters from the tip of the lantern.Next, the physician attempted to advance a pc400 through the lantern; however, resistance was encountered approximately 30 centimeters from the tip of the lantern and the pc400 became stuck.Therefore, the physician decided to withdraw the pc400; however, the pc400 unraveled and unintentionally detached.Therefore, the lantern containing the pc400 was removed.The procedure was completed using a new lantern and additional pc400s.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: 7716490
• Report Number: 3005168196-2018-01437
• Device Sequence Number: 19058525
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• 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): 06/24/2018
• 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: 03/29/2025
• Device Catalogue Number: 4004C0513
• Device Lot Number: F75331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• 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: 06/24/2018
• Initial Report FDA Received Date: 07/24/2018
• 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