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

Catalog Number	4002C2060
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
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 reported issue cannot be confirmed and 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 numbers: 3005168196-2017-01692, 3005168196-2017-01693.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the shunt route (between the splenic vein and the renal vein) using penumbra coils 400 (pc400s), a px slim delivery microcatheter (px slim) and penumbra coil detachment handles (handles).During the procedure, while attempting to advance a pc400 through the px slim, the physician experienced resistance after advancing the pc400 30 centimeters into the px slim; therefore, it was removed.The physician then flushed the px slim and re-attempted to advance the pc400; however, resistance was encountered again and therefore, the coil was removed.After that, the physician opened a new pc400, advanced it into the target vessel and attempted to detach it using a handle; however, the pc400 failed to detach.Therefore, the physician manually broke the pc400 pusher assembly and manually detached the coil.The procedure was completed using additional pc400s, the same px slim and a new handle without further issues.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: 6898951
• Report Number: 3005168196-2017-01691
• Device Sequence Number: 1223883
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 01/08/2025
• Device Catalogue Number: 4002C2060
• Device Lot Number: F73659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 70