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

Catalog Number	4004C0820
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
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 in multiple locations.The embolization coil was entrapped within the snare and detached from the pusher assembly and unraveled, and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned devices revealed the embolization coil was detached from the pusher assembly and unraveled, and the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance, and will allow the embolization coil to detach and unravel.The embolization coil may have become further damaged during retrieval via the snare.Further evaluation revealed a 0.025¿ mandrel could be advanced through the px slim without issue.The px slim had no visible damage.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using penumbra coils 400 (pc400¿s).During the procedure, the physician successfully deployed and detached a pc400 in the target vessel using a px slim delivery microcatheter (px slim).The physician then advanced another pc400 in the target vessel using the same px slim; however, while manipulating the px slim and the pc400 in the patient¿s body, the physician noticed under fluoroscopy that the pc400 appeared to be lengthened.It was confirmed that the pc400 became unraveled in the patient¿s body; therefore, the physician used a snare device to grab the px slim and remove the unraveled pc400.The physician then took an angiography which revealed that the blood flow had decreased; therefore, the procedure was completed at this point.It should be noted that the physician did not used a rotating hemostasis valve (rhv) and did not maintain continuous flush throughout the procedure; however, manual flush was performed after each coil insertion.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: 6424478
• Report Number: 3005168196-2017-00421
• Device Sequence Number: 18970398
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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): 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/16/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F72323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 63