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

Catalog Number	4002C2060
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-00081, the hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400''s (pc400s).It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician placed a non-penumbra catheter in the celiac artery, then advanced a lantern delivery microcatheter (lantern) toward the target vessel.Next, the physician deployed and detached an initial pc400 in the target vessel using the lantern.After that, the physician flushed the lantern, then attempted to advance a new pc400 through the lantern; however, the pc400 would not exit the tip of the lantern.The physician did not mention feeling any resistance prior to the pc400 becoming stuck.The physician then repositioned the tip of the lantern and re-attempted to advance the pc400 out of the tip of the lantern; however, the pc400 would not advance and could only be retracted.Therefore, the pc400 was removed and advanced out of its introducer sheath and into saline to check for damages but no abnormalities were observed.The physician then made another attempt to advance the same pc400 through the lantern but the same issue occurred.Thus, the pc400 was removed and a new pc400 was opened.While attempting to advance the new pc400 through the same lantern, the physician did not mention any resistance; however, the same issue occurred.Therefore, the new pc400 was removed.After that, the physician removed the lantern for visual inspection and did not observe any damages.Therefore, the procedure was completed using additional coils 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: 7173700
• Report Number: 3005168196-2018-00080
• Device Sequence Number: 10992358
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2017

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: Physician
• Device Expiration Date: 01/04/2025
• Device Catalogue Number: 4002C2060
• Device Lot Number: F73545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR